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Intellectual Property and Public Health in the Developing World

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Monirul Azam

4. The Globalising Standard of Patent Protection in WTO Law and Policy Options for the LDCs: The Context of Bangladesh

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4.1 Introduction

1This chapter analyses the globalising standard of patent protection as adopted under the TRIPSAgreement of the WTO and measures it against the experiences of Brazil, India and South Africa in order to identify possible options for the LDCs,1 with special reference to pharmaceutical patent issues. The developed member states of the WTO negotiated mandatory protection for pharmaceutical products and processes in the TRIPS Agreement, on the basis that such mandatory protection would provide the incentive for continued pharmaceutical innovation. In contrast, the developing countries and LDCs argued that enacting patent laws that comply with the TRIPS Agreement would restrict production and supply of low-cost generic medicines by their local pharmaceutical industries or by the pharmaceutical industries in other developing countries, and hence could increase the price of pharmaceuticals to the point that they become inaccessible to their populations.

  • 2 GATT, Negotiating Group on TRIPs, ‘Including Trade in Counterfeit Goods’, Meeting of Negotiating Gr (...)
  • 3 See Michael Blakeney, Trade Related Aspects of Intellectual Property Rights: A Concise Guide to the (...)
  • 4 ‘How to Comply with the TRIPS and WTO Law’, p. 42.

2During the TRIPS negotiations, it was argued that the principle of a balance of rights and obligations was required because IP owners needed to undertake certain obligations in return for the exclusive rights conferred on them, and also to allow governments to take remedial measures in the case of non-fulfilment of these obligations so that IPRs could promote industrial creativity to benefit society in general.2 This principle was generally recognised in pre-existing IP conventions and in the national laws of many countries:3 “The acceptance of this principle was aimed at assuring the access of developing countries to modern technology, eliminating non-use, misuse or abusive use of IPRs, especially with a view to avoiding trade distortions, and allowing the flexibility in the intellectual property protection for the public interest and the developmental and technological needs of developing countries” and LDCs.4

  • 5 See Negotiating Group on TRIPs, ‘Including Trade in Counterfeit Goods’, Meeting of Negotiating Grou (...)
  • 6 TRIPS Agreement, art. 8.2.

3Therefore, the principle of balance of rights and obligations could be used while also employing other flexibilities of the TRIPS Agreement. It was further suggested that the TRIPS Agreement should take into account the application of the GATT principle of securing a balance of rights and obligations among parties.5 However, as in the case of the principle of public interest, the application of the principle of balance of rights and obligations was adopted with the lock of the consistency test. As worded in TRIPS Article 8.2, any measure taken under the umbrella of this article must be “consistent with” the provisions of the TRIPS Agreement.6 Moreover, the extents to which a practice is regarded as “unreasonably” restraining trade or “adversely” affecting the international transfer of technology and to which a national response against such practices is regarded as an appropriate measure are ambiguous under article 8.2. These unclear conditions leave room for interpretation, and create difficulties in applying the principle of balance of rights and obligations. Considering the room for interpretation of TRIPS flexibilities and practices for countries like India, Brazil and South Africa, this chapter explores possible options for Bangladesh while it complies with patent provisions under the TRIPS Agreement.

  • 7 For example, Brazil implemented a system of compulsory licensing. See ‘The Politics of Patents and (...)
  • 8 For example, the DSB of the WTO established a panel, as requested by the US, to look into the compl (...)
  • 9 Rochelle C. Dreyfuss, ‘The Role of India, China, Brazil and Other Emerging Economies in Establishin (...)
  • 10 Susan K. Sell, ‘TRIPS Was Never Enough: Vertical Forum Shifting, FTAS, ACTA and TPP’, Journal of In (...)

4Brazil, India and South Africa used TRIPS flexibilities in different ways to modify their national patent regimes to become TRIPS- compliant,7 though they experienced some difficulties with respect to the legislative measures they enacted.8 However, the legislative provisions were found to be within the scope of the flexibilities of the TRIPS Agreement. Bangladesh, as an LDC, faces similar public health challenges but also has the potential to become a substantial (global) producer of generic medicines. The need to balance these competing interests (pharmaceutical innovation and access to pharmaceuticals) means that there are good grounds for Bangladesh to use the Indian, Chinese, Brazilian and South African experiences as a way to guide Bangladesh’s legislative transition to a TRIPS-compliant patent regime. It is crucial for Bangladesh to use these experiences to develop IPR policies that preserve the full complement of TRIPS flexibilities. In this regard, a comment by Rochelle Cooper Dreyfuss is worth noting: “These practices [of India, Brazil, South Africa, and other developing countries] achieve international recognition as they are defended in international courts and put on the agendas of international organizations”.9 Therefore, “domestic actors then may interpret the law in a particular way that allows them to offer a new approach that others may choose to emulate”.10 While evaluating the possible policy options for LDCs to balance pharmaceutical innovation and access to medicines against the experiences of Brazil, India and South Africa in complying with the TRIPS-compliant patent law, relevant discussions, policies and recommendations as formulated in the WHO will also be indicated. The discussions here do not use the experience of China, because China has a very strong technological base, critical bargaining capacity and substantial market power; therefore the Chinese perspective is not relevant for the LDCs.

5This chapter explores possible legislative and government intervention options for Bangladesh, utilising the experiences of Brazil, India and, to some extent, South Africa (as the South African patent law has yet to introduce a substantive patent examination process, some of the important policy options such as disclosure, high threshold, novelty, pre-grant and post-grant requirements have not been well tested in South Africa). It also reflects on the relevant policy issues and recommendations from the WHO. This chapter uses legal doctrinal analysis, comparative review and field research in Bangladesh, by way of surveys and interviews aimed at understanding stakeholders’ perceptions of the various policy options available under the TRIPS Agreement. The field research in Bangladesh analysed in depth the situation at the DPDT11 and the DGDA12 to understand the ongoing roles of these two important regulatory bodies during the TRIPS waiver period and their possible roles in a post-TRIPS setting.

4.2 Legislative Options for Bangladesh

6Drawing on the Brazilian, Indian and South African experiences, a number of legislative options should be considered by Bangladesh in introducing TRIPS-compliant patent law to help preserve its local pharmaceutical industry and to promote innovation and access to medicine. For the purposes of this chapter, the legislative options include (i) having a high threshold for patentability and exclusion from patentability provisions, (ii) having a best mode patent disclosure and disclosure of origin, (iv) narrowing the scope of patent claims, (iv) providing exceptions to product patent rights such as early working, parallel imports, and research and experimental use exceptions, (v) having a strong compulsory licensing mechanism, (vi) having prior use exceptions, (vii) having pre-grant and post-grant oppositions, (viii) making the duration of patent protection subject to exceptions and (ix) not adopting overprotective enforcement provisions. Each of these options will be examined in turn.

4.2.1 A High Threshold and Exclusion Clause

  • 13 TRIPS Agreement, art. 27.1 (providing that “patents shall be available for any inventions, whether (...)

7Under the TRIPS Agreement, patent protection must be granted for products and processes that are new, involve an inventive step and are industrially applicable.13 The definition of an invention itself constitutes a key aspect of any patent policy with implications in other areas, such as industrial and public health policies. Therefore, with countries that are net importers of technologies, their priority should be to focus on narrowing the scope of patentability and incorporating as many exceptions as possible under the national patent law to facilitate development of a viable technological base. This also applies in the case of pharmaceutical products.

  • 14 See Mohammed El Said, ‘The Implementation Paradox: Intellectual Property Regulation in the Arab Wor (...)
  • 15 Ibid., 229.

8The TRIPS Agreement did not define the criteria for patent protection; therefore, these criteria can be interpreted and applied by member states in accordance with their national priorities and developmental goals.14 For example, the TRIPS Agreement “does not specify the patenting of new uses of known products, including pharmaceutical drugs, thus allowing member countries the possibility of rejecting these new uses for lack of novelty, inventive step or industrial applicability”.15

  • 16 See ibid., Article 27.1, which reads: Subject to the provisions of paragraphs 2 and 3, patents shal (...)

9The TRIPS Agreement considers novelty to mean that the invention is not already part of an existing invention and involves an inventive step.16 Considering the importance of having a high threshold for patentability in countries like Bangladesh, Tony VanDuzer states:

  • 17 Tony VanDuzer, ‘TRIPS and Pharmaceutical Industry in Bangladesh: Towards a National Strategy’ (Pape (...)

It is a common practice of patent owners in the pharmaceutical sector to seek to extend the effective duration of patent protection by obtaining a second later patent on a new mode of delivery of a patented drug (such as capsules instead of tablets) or some other small change in a patented product. Setting high standards for novelty and inventive step would help to ensure that a patent on a product was not, in effect, extended by a subsequent patent on a trivial improvement.17

Justifying the non-granting of patents for new uses or second uses, Correa remarks:

  • 18 Intellectual Property Rights, The WTO and Developing Countries, p. 56.

Such an invention relating to the use of a product may be deemed as non- patentable because it consists of the discovery of an existing property rather than a new development, or because it falls under the exclusion from patentability (allowed by the [TRIPS] Agreement and most national laws) of therapeutical methods.18

  • 19 See Carlos Correa, ‘Guidelines for the Examination of Pharmaceutical Patents: Developing a Public H (...)
  • 20 See Ibid., p. 1.

10It is feared that awarding protection to new uses of medicines will stifle innovation and restrict the ability of pharmaceutical companies in developing countries and LDCs to produce advanced medications needed for eradicating local disease.19 This requirement could also block the introduction of generics, particularly in those countries where pharmacy laws do not permit generic substitution and/or generic prescribing.20 This will have anti-competitive consequences and result in higher prices for medications.

11In this regard, the CIPIH Report provides that:

  • 21 WHO, ‘Public Health, Innovation, and Intellectual Property Rights: Report of the Commission on Inte (...)

Governments should take action to avoid barriers to legitimate competition by considering developing guidelines for patent examiners on how properly to implement patentability criteria and, if appropriate, consider changes to national patent legislation.21

12Again, the UK IPR Commission recommends that :

  • 22 Commission on Intellectual Property Rights, ‘Integrating Intellectual Property Rights and Developme (...)

Most developing countries, particularly those without research capabilities, should strictly exclude diagnostic, therapeutic and surgical methods from patentability, including new uses of known products.22

  • 23 J.H. Reichman, ‘From Free Riders to Fair Followers: Global Competition under the TRIPS Agreement’, (...)

13On the one hand, “there is no agreed international standard of absolute novelty, and, within limits, the developing countries may pick and choose from among the different approaches recognized in the domestic patent laws”,23 but on the other, the manner of dealing with the issue of the scope of patentability differs from one country to another because this issue relies heavily on each country’s level of progress, development and technological capability.

14Further, in addition to the flexibility awarded in drafting its patentability criteria, the TRIPS Agreement provides for a number of exemptions that may be excluded from patentability. Article 27.2 of TRIPS states:

  • 24 TRIPS Agreement, art. 27.2.

Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.24

15The fact that the TRIPS Agreement does not define “protect ordre public or morality” gives member states additional room for flexibility.

  • 25 See Reichman (1997), p. 93.
  • 26 ‘Product Patents and Access to Medicines in India’, pp. 326, 334.
  • 27 The Patents Act, 1970, § 2(ja), No. 39, Acts of Parliament, 1970 (India).
  • 28 Ibid., § 2(ta).
  • 29 Ibid., § 3(d).

16The existing patent law of Bangladesh, the PDA, contains no legislative provision regarding the patentability of a pharmaceutical product and no provision detailing excluded categories of inventions. By defining thresholds to impose a significant requirement for novelty, Bangladesh could ensure that trivial improvements in technology do not receive patent protection. India adopted such an approach in its amended Patent Act, 2005.25 The Patent Act, 2005 restricts the scope for granting patents based on frivolous claims26 and clarifies that an “inventive step” means a feature of an invention that “involves technical advances as compared to the existing knowledge or having economic significance or both”.27 It also provides a definition for “pharmaceutical substance” as being “a new entity involving one or more inventive steps”,28 and that “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy” is not patentable.29

  • 30 The Patents (Amendment) Act, 2005, § 3(b), No. 15, Acts of Parliament, 2005 (India).
  • 31 Ibid., § 3(p).
  • 32 Email Interview with a patent law academic in Delhi, India, 10 March 2012.
  • 33 See generally ‘Trips Compliant Patent Law’, p. 141.
  • 34 In 2001, a draft patent law was prepared by the Law Commission of Bangladesh in consultation with t (...)
  • 35 Draft Patents and Designs Act, 2010 § 3, 2010 (Bangl.).
  • 36 Ibid., § 4.

17In an attempt to ensure access to medicine, section 3(b) of the Indian Patent Act, 2005 excludes from patentability “an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment”.30 Section 3(p) excludes patenting of “an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components”.31 This provision is an attempt to avoid bio-piracy and ensure that traditional knowledge, whether handed down or developed, is incapable of being captured by patents. One interview participant commented that Section 3 of the Patent Act, 2005 is a powerful instrument to prevent frivolous patents and the abuse of traditional knowledge and resources in India.32 Given the absence of patentability and exclusion clauses in the existing patent law of Bangladesh, such legislative provisions should be considered by Bangladesh as it moves towards TRIPS compliance. These provisions comply with the TRIPS Agreement, and are justified on the basis that limiting the availability of patents should promote competition in the local market.33 However, the Draft Patents and Designs Act, 2010 of Bangladesh (the Draft PDA)34 includes provisions on patentable inventions35 and exclusion from patentability.36 Unlike the Indian patent law provisions, these provisions fail to utilise the high threshold of patentability options effectively because they lack a provision covering pharmaceutical substances, an exclusion clause pertaining to mere improvement and protection from abuse of traditional knowledge. The Draft PDA tries to extend the ambit of prior art under the definition of novelty:

  • 37 Ibid., § 5(2).

prior art in the case of an invention shall be taken to comprise-(a) all matter, whether a product, a process, information about either, or anything else, made available to the public anywhere in the world, by written or oral description, by use or in any other way, at any time prior to the filing or, as the case may be, the priority date, of the application for patent claiming the invention.37

18However, this provision may not be effective without a specific exclusion clause; therefore, these provisions should be revised in light of the Indian Patent Act, 2005.

  • 38 Based on the survey data, this position has been supported by the majority of large, medium and sma (...)
  • 39 This has been remarked on by the CEO of an MNPC operating in Bangladesh.

19Local pharmaceutical companies in Bangladesh view this provision as very important for generic producers and consumers because it will increase competition in the local market.38 However, MNPCs argue that a high threshold for patentability will exclude local inventions, which would not benefit society.39 The middle ground would suggest that such a provision will balance the need to maintain and support innovation with the need for access to pharmaceuticals.

4.2.2 Best Mode Disclosure and Disclosure of the Source of Genetic Resources and Traditional Knowledge

  • 40 Correa (2006), p. 4.
  • 41 Ibid.

20As the aim of the patent regime is the disclosure of information and spread of knowledge, a “[l]ack of sufficient disclosure may be a reason for refusal result in the rejection of an application or invalidation of a patent”.40 Correa stresses that “[t]his requirement has particular importance in the chemical and pharmaceutical fields to enable the reproduction of the invention during the patent term (for instance, in the case of a compulsory license) or after patent’s expiry”.41

  • 42 TRIPS Agreement, art. 29.
  • 43 Ibid.
  • 44 Ibid.
  • 45 See generally Bingbin Lu, ‘Best Mode Disclosure for Patent Applications: An International and Compa (...)

21Article 29 of the TRIPS Agreement requires that an applicant for a patent disclose the invention “in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art”,42 which “may also require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date”.43 The absence of strong disclosure requirements will have long-term negative implications for innovation, technology transfer and the dissemination of technology in the pharmaceutical sector in developing countries.44 It will likely strengthen the monopolistic position of MNPCs by preventing local pharmaceutical companies from benefiting from the disclosed technical information and by precluding efforts in R&D based on that information.45

  • 46 PDA, § 4, effective 26 March 1971 by virtue of the Laws Continuation and Enforcement Order of 25 Ma (...)

22Section 4(2) of Bangladesh’s PDA simply states that “a complete specification must particularly describe and ascertain the nature of the invention and the manner in which the same is to be performed”.46 Bangladesh should take advantage of Article 29 of the TRIPS Agreement by requiring disclosure of the best known mode for carrying out the invention and also stipulating that the disclosure enable the execution of all embodiments of the invention.

  • 47 Interview with a pharmacist from a leading local pharmaceutical company, in Dhaka, Bangladesh, 3 Ma (...)
  • 48 Interview with an examiner at the DPDT, in Dhaka, Bangladesh, 1 March 2009.

23During an interview, one participant argued that given the weakness of the existing provisions, patent applications in Bangladesh are typically ambiguous. Often it is difficult to ascertain a precise description of the invention, which ultimately frustrates the objective of granting a patent in exchange for sufficiently disclosing the invention to contribute to technical learning and teaching.47 One participant argued that the ultimate benefit of disclosing an invention is the further development of that particular invention, which leads to increased competition in the marketplace; thus, after the expiry of the patent term, competitors can enter the market with more viable options.48

  • 49 Lei No. 9.279 art. 24, de 14 de maio de 1996, Diario Oficial Da Uniao [DOU] de 15.05.1996. (Braz.), (...)

24Both India and Brazil have adopted the best mode disclosure approach. Section II, Article 24 of the Brazilian Industrial Property Law provides that the “specifications shall clearly and sufficiently describe the object, so as to permit its reproduction by a technician versed in the subject, and shall indicate, when applicable, the best way of doing it”.49 On the other hand, section 10(4) of the Indian Patent Law, 1970 requires that every complete specification shall:

  1. fully and particularly describe the invention and its operation or use and the method by which it is to be performed;

  2. disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection.50

25Therefore, Bangladesh should adopt a similar requirement to facilitate innovation and the development of competing products. It is worth noting that section 11 of the Draft PDA of Bangladesh includes a provision demanding that every complete specification shall:

  1. fully and particularly describe the invention and the method by which it is to be performed

    • 51 Draft Patents and Designs Act, 2010 § 11, 2010 (Bangl.).

    disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection.51

  • 52 See WTO Council for TRIPS, ‘Elements of the Obligation to Disclose the Source and Country of Origin (...)
  • 53 See WTO Public Symposium, ‘Disclosure Requirements: Incorporating the CBD Principles in the TRIPS A (...)
  • 54 Tove Iren S. Gerhardsen, ‘Developing Countries Propose TRIPS Amendment on Disclosure’, Intellectual (...)

26Adoption of this provision would help the DPDT of Bangladesh to reject patent applications if the inventions are not sufficiently disclosed. However, best mode disclosure does not necessarily require disclosure of origin, and hence may not prevent abuse of genetic resources and traditional knowledge. This has led a number of developing countries, including Brazil and India,52 to debate in the WTO the question of “whether and how patent applicants should be obliged to disclose the origin or source of the genetic resource and traditional knowledge used in an invention and provide evidence of prior informed consent and benefit sharing”.53 As TRIPS Article 29 does not specifically require disclosure of origin, developing countries are requesting amendments to the TRIPS Agreement to ensure that the necessary requirements are incorporated into patent application procedures.54

  • 55 See WTO Council for TRIPS, Article 27.3(b), ‘Relationship Between the TRIPS Agreement and the CBD, (...)
  • 56 Working Group on Reform of the Patent Cooperation Treaty (PCT), WIPO, International Patent Cooperat (...)
  • 57 See WIPO Intergovernmental Committee on Intellectual Property, and Genetic Resources, Traditional K (...)
  • 58 Felix Addor, WTO Public Symposium, ICTSD/CIEL/IDDRI/IUCN/QUNO, ‘Dialogue on Disclosure Requirements (...)
  • 59 “A number of countries … have already [incorporated] disclosure of origin requirements (in differen (...)
  • 60 Interview with an IP lawyer working as a legal adviser and practitioner at the Supreme Court, in Dh (...)

27Switzerland also made proposals relating to disclosure of origin to the WTO/TRIPS Council,55 to the WIPO Working Group on Reform of the Patent Cooperation Treaty, 1970 (PCT 1970)56 and to the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore.57 In Switzerland’s opinion, “the provisions of the TRIPS Agreement provide for adequate flexibility with regard to a formal requirement to disclose the source. Accordingly, Switzerland does not consider it necessary to amend the TRIPS Agreement”.58 Consequently, it can be said that TRIPS Article 29 does not prevent the introduction of the requirement to disclose the source within the national legislation.59 In the context of Bangladesh, one interviewee argued that “in the absence of qualified and experienced examiners, best mode disclosure and disclosure of origin provisions would have little effect”.60

  • 61 See Draft Patent Ain (Law), 2012 § 15, 2012 (Bangl.).

28In Bangladesh, neither the existing PDA nor the Draft PDA includes any provision on the disclosure of origin. However, the Draft Patent Law, 2012 states under section 15 that patents on genetic resources or traditional knowledge could be granted provided that the procedure of “relevant authority and related rules” is followed, and, before such patents are granted, due consideration must be given to the issues of public order and morality.61 There is no explanation or indication in the draft law regarding “relevant authority and rules”, nor is there an existing authority in Bangladesh that deals with the issues of genetic resources or traditional knowledge. Therefore, Bangladesh should amend the proposed law, preferably to include disclosure of origin as part of patent application requirements rather than in a separate provision.

29In addition to high-level disclosure, limiting the scope of patent claims may also be useful for Bangladesh.

4.2.3 Narrowing the Scope of Patent Claims

30In a 2003 report, VanDuzer states:

  • 62 ‘TRIPS and Pharmaceutical Industry in Bangladesh’, p. 33.

The broader the claims that an inventor can make under [a patent] law, the wider the monopoly the inventor can obtain. Broad claims reduce the scope for competing products in the market, whereas narrow claims create greater opportunities for innovation and competition. National laws vary in the nature and breadth of claims permitted. In relation to pharmaceutical products claims can be restricted to the chemical structure or composition of a new product … The TRIPS Agreement is silent on the form of and limits on allowable claims and so Bangladesh would be free to adopt a patent law that requires that pharmaceutical patent claims be limited to the precise chemical composition of the product.62

  • 63 PDA § 4(3), 1911 (Bangl.).
  • 64 Lei No. 9.279 art. 25, de 14 de maio de 1996, Diario Oficial Da Uniao [DOU] de 15.05.1996. (Braz.), (...)
  • 65 Interview with a pharmaceutical researcher at the University of Dhaka, in Dhaka, Bangladesh, 12 Mar (...)

31Section 4(3) of the PDA of Bangladesh provides that a specification, whether provisional or complete, must commence with the title, and in the case of a complete specification must end with a distinct statement of the invention claimed.63 Based on this provision, the law is not able to facilitate the narrowing of coverage of pharmaceutical patents, but rather encourages applications for broad patents. By way of comparison, Brazilian legislation provides that “[t]he claims shall be substantiated in the specifications, characterizing the particulars of the application, and clearly and precisely defining the subject matter that is the object of the protection”.64 During an interview, one participant argued that most of the pharmaceutical patents granted in Bangladesh prior to the suspension of pharmaceutical patents in 2008 were based on broad claims, which in the future may restrict the production of generic pharmaceuticals.65 Therefore, Bangladesh should adopt provisions similar to those of Brazil that narrow the ability to claim a pharmaceutical patent on broad claims. However, to encourage further development and innovation on any patented product, additional exceptions are necessary to facilitate generic competition and cheaper products for consumers. Such exceptions include early working, a research and experimental use exception, and parallel imports.

4.2.4 Exceptions to Product Patent Rights

32Patent rights are not absolute but are subject to certain limitations and exceptions. These limitations and exceptions are often designed to foster and promote technology transfer, to prevent the abuse of IP, to foster research and innovation, and to protect public policy priorities including public health.

  • 66 TRIPS Agreement, art. 30.
  • 67 Ibid.
  • 68 Mohammad Monirul Azam and Yacouba Sabere Mounkoro, Intellectual Property Protection for the Pharmac (...)

33Article 30 of the TRIPS Agreement permits member countries to “provide limited exceptions to the exclusive rights conferred by a patent”.66 That article does not list the specific acts for which exceptions can be provided. What it says is that such exceptions should satisfy certain conditions that do not “unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties”.67 The TRIPS Agreement does not contain any explanation of the terms “limited exceptions”, “unreasonably conflict”, “legitimate interests” and “hence the use of this provision depends on the interpretation of these conditions”.68 There are two exceptions used by India and Brazil in their legislative framework: (i) early working (Bolar exemptions), and research and experimental use; and (ii) parallel importing.

4.2.5 Early Working (or Bolar Exceptions), Research and Experimental Use

  • 69 Roche Prods., Inc. v. Bolar Pharm. Co., 733 F. 2d 858 (Fed. Cir. 2006); see Anshull Mittal, ‘Patent (...)
  • 70 Bolar Pharm., 733 F.2d at 861.
  • 71 Ibid., 861–62.
  • 72 Ibid., 862.

34The early working exemption is commonly referred to as the “Bolar” provision or exception, as it derives from Roche Products, Inc. v. Bolar Pharmaceutical Co.,69 which concerned the manufacturing of generic pharmaceuticals. Bolar Pharmaceutical was the generic drug manufacturer and Roche Products was the pharmaceutical company that made and sold Valium, the active ingredient of which was patented.70 Before the patent expired, Bolar used the patented chemical in experiments to determine if its generic product was the bioequivalent to Valium, and thus could be given US Food and Drug Administration (FDA) approval for its generic version.71 Bolar argued that its use of the patented product was not an infringement based on the experimental use exception and that public policy favoured the availability of generic drugs immediately following a patent’s expiration.72

  • 73 ‘Patent Linkage in India’, p. 193.
  • 74 See ibid.

35The Court of Appeals for the Federal Circuit “rejected Bolar’s contention holding that the experimental use exception did not apply because Bolar intended to sell its generic product in competition with Roche’s Valium after patent expiration and, therefore, Bolar’s experiments had a business purpose”, and did not qualify for the statutory exception.73 The court recognised that any change to the patent law needed to be made by Congress.74

  • 75 Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98–417, 98 Stat. 1585 ( (...)
  • 76 In the US, this exemption is also technically called the § 271(e)(1) exemption or Hatch–Waxman exem (...)

36Shortly after the Bolar Pharmaceutical case was decided, Congress passed a law permitting the use of patented products in experiments for the purpose of obtaining US FDA approval.75 As a result of this change, exceptions for early working gained momentum and now Bolar exceptions have been enacted in most jurisdictions.76

  • 77 ‘Intellectual Property Protection for the Pharmaceuticals’; see also Canada—Patent Protection of Ph (...)
  • 78 CIPIH Report, p. 24.

37Importantly, the WTO Dispute Panel upheld the use of the Bolar exception as conforming to the requirements of the TRIPS Agreement in the Canada–EU dispute.77 Supporting the inclusion of an early use exception, the CIPIH Report recommended that “Countries should provide in national legislation for measures to encourage generic entry on patent expiry, such as the ‘early working’ exception, and more generally policies that support greater competition between generics, whether branded or not, as an effective way to enhance access by improving affordability”.78

  • 79 Mohammed K. El Said, Public Health-related TRIPS-Plus Provisions in Bilateral Trade Agreements: A P (...)
  • 80 Ibid. According to Oh and Musungu, “[n]ational laws reviewed in Latin American and Caribbean countr (...)
  • 81 El Said, ‘Public Health Related TRIPS-Plus Provisions’; see also ‘Exception to Patent Rights in Dev (...)

38In addition to the Bolar exception, the “exception for research or experimental use of an invention also falls under the Article 30 category of exceptions”.79 This exception is extensively used in many national patent laws around the world.80 It “allows the use of a patented product in experimentation, for both scientific as well as commercial purposes, without the consent of the patent holder. This exception plays a significant role in the process of encouraging innovation, dissemination of knowledge and transfer of technology”.81

39This kind of exception is important for maintaining and developing efficient alternatives to protect public health and to encourage innovation within the industry. The opportunity to use patented products for R&D purposes will enable indigenous firms to be ready with efficient processes and use these whenever they are permitted to do so.

  • 82 ‘Intellectual Property Protection for the Pharmaceuticals’.

40The existing patent law of Bangladesh under section 21 provides for experimental use exceptions. However, the language and process as mentioned in the existing PDA are so ambiguous and complicated that it will have no positive effect. The law must be amended to simplify the entry of generic pharmaceuticals into the market. The research and experimental provision “is very important for generic entry. It permits generic entry soon after the patents expire and hence allows the consumers to benefit from competition and lower prices without delay. In the absence of it, generic companies will have to wait till[sic] the patents actually expire before they can start the tests necessary for getting regulatory approval”.82

  • 83 Ibid.

41It will take time to get such approvals and without such an exception, “the patentee will effectively enjoy monopoly status even though there are no legal barriers to entry”.83 However, the Draft PDA tries to simplify the process, stating that:

  • 84 Draft Patents and Designs Act, 2010 § 48(c), 2010 (Bangl.).

[A]ny machine, apparatus or other article in respect of which the patent is granted or any article made by the use of the process in respect of which the patent is granted, may be made or used, and any process in respect of which the patent is granted may be used, by any person for the sole purpose merely of experiment or research including the imparting of instruction to pupils.84

  • 85 See Shamnad Basheer, ‘India’s Tryst with TRIPS: The Patents (Amendment) Act, 2005’, Indian Journal (...)

42Nonetheless, the exemption as laid down in the Draft PDA may not be enough if a generic producer wants to use it for experimental purposes leading to the collection of data to be submitted to the drug approval authority for the production of on-patent drugs.85 In the context of the terms of the legislative provision itself, guidance can be sought from section 107A(a) of the Indian Patent Act, 2005, which declares:

  • 86 Patent (Amendment Act), 2002, § 107A(a), 2002 (India).

[A]ny act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product … shall not be considered as an infringement of patent rights.86

  • 87 During surveys, most local pharmaceutical companies in Bangladesh, irrespective of size, supported (...)
  • 88 In the survey feedback, MNPCs did not answer this question, but during interviews they opposed the (...)
  • 89 Interview with an official from a public health NGO, in Dhaka, Bangladesh, 9 February 2009.

43In Bangladesh there are diverging opinions within the pharmaceutical industry regarding this. During interviews, most representatives of the local pharmaceutical industry87 strongly supported the inclusion of this provision to benefit generic producers, whereas MNPCs88 thought it might discourage investment and technology transfer in the pharmaceutical sector. One interview participant argued that in the absence of a research and experimental use provision, generic producers in Bangladesh would be restricted from experimenting with patented products.89

44Arguably, the absence of a research and experimental use provision encourages the high pricing of pharmaceuticals, given the monopoly of a patent holder. Therefore, the present provision in Bangladesh needs to be extended to include a similar provision to that of India to facilitate the generic entry of patented drugs as early as possible after the introduction of pharmaceutical patents in Bangladesh. As part of the transition to a TRIPS-compliant regime, the legislative option of including both an early working and a research and experimental use exemption should be considered.

45A further exemption that demands attention is the practice of permitting parallel imports.

4.2.6 Parallel Imports

  • 90 TRIPS Agreement, art. 28.1(a).
  • 91 TRIPS Agreement, art. 6.
  • 92 WHO, ‘Intellectual Property Protection: Impact on Public Health’, WHO Drug Information 19 (2005): 2 (...)

46The TRIPS Agreement provides that the patent owner has the exclusive right to prevent others not only from making, using or selling the invented product or process in the country, but also from importing the product from other countries.90 However, this right is subject to Article 6 of the TRIPS Agreement, which deals with the principle of “exhaustion”91 and states that “once patent holders have sold a patented product, they cannot prohibit the subsequent resale [or import] of that product since their rights in respect of that market have been exhausted by the act of selling the product”.92 With respect to patent exhaustion as it relates to parallel imports, Sudip Chaudhuri writes:

  • 93 Sudip Chaudhuri, ‘Indian Generic Companies, Affordability of Drugs and Local Production in Africa w (...)

Such imports of patented products without the consent of the patent holder in the importing country are known as parallel imports. This is very important in the pharmaceutical industry because the same patented medicine is often sold at different prices in different countries and hence parallel imports permit a country to shop around for the lowest price. The underlying justification of allowing parallel imports is that since the innovator has been rewarded through the first sale of the product, its patent rights have been “exhausted” and hence it should have no say over the subsequent re-sale.93

  • 94 Doha Declaration, art. 5(d); Sudip Chaudhuri (2008).

47Article 6 of the TRIPS Agreement was further clarified by the Doha Declaration, which stipulated that each country was “free to establish its own regime for such exhaustion without challenge”.94

  • 95 See generally Marco C.E.J. Bronckers, ‘The Exhaustion of Patent Rights under World Trade Organizati (...)
  • 96 N. Lalitha, ‘Doha Declaration and Public Health Issues’, Journal of Intellectual Property Rights 13 (...)
  • 97 Ibid.
  • 98 Ibid.
  • 99 Ibid. A submission to the World Health Organization stated: Article 7 is a key provision that defin (...)
  • 100 Lalitha (2008).
  • 101 Rohit Malpani, ‘All Costs, No Benefits: How TRIPS-plus Intellectual Property Rules in the US–Jordan (...)

48There are three kinds of exhaustion regimes for the purpose of parallel imports: national, regional and international.95 The US has adopted “a national exhaustion principle whereby the patent owner has no control over the product once it is placed in the domestic market”; however, the patent holder “can exercise his rights outside the US market regarding the price and quantity of the product”.96 In contrast, the EU has adopted a “regional exhaustion principle whereby the rights are exhausted within” the boundaries of the EU.97 By comparison, international exhaustion has no jurisdictional limit; the rights of the patent owner are exhausted once he has sold his product.98 International exhaustion is consistent with the objective of Article 7 of the TRIPS Agreement.99 The advantage of international exhaustion is that developing countries can scout for lower-priced patented products anywhere in the world.100 Research conducted in a number of countries supports this claim. In Kenya, for example, it was found that “parallel importation reduced the price of first-line ARV medicines to one-third of the price of the patented version”.101 In this regard, the Report on the Commission of Intellectual Property Rights (UK) states:

  • 102 Integrating Intellectual Property Rights’, p. 52.

Developing countries should not eliminate potential sources of low cost imports from other developing or developed countries. In order to be an effective pro-competitive measure in a scenario of full compliance with TRIPS, parallel imports should be allowed whenever the patentee’s rights have been exhausted in the foreign country. Since TRIPS allows countries to design their own exhaustion of rights regimes (a point restated at Doha), developing countries should aim to facilitate parallel imports in their legislation.102

  • 103 See CIPIH Report, p. 124.

49Moreover, the CIPIH Report, Recommendation 4.19, declares that “[d]eveloping countries should retain the possibilities to benefit from differential pricing, and the ability to seek and parallel import lower- priced medicines”.103

  • 104 This remark was made by an official from a leading MNPC operating in Bangladesh during an interview (...)
  • 105 Ibid.
  • 106 Interview with a policy analyst from an international NGO working in Bangladesh, Dhaka, Bangladesh, (...)
  • 107 Ibid.

50In the context of Bangladesh, one pharmaceutical market expert argued that “international exhaustion will be of no benefit for Bangladesh; rather, it will increase counterfeiting and low‑quality medicine in the local market”.104 He also indicated that allowing cheaper medicines from alternative sources may jeopardise the entire pharmaceutical market in Bangladesh with regard to the institutional and infrastructural limitation of the DDA, because it would open the flood gates for different products, making it impossible for the DDA to inspect and monitor all the possible cheaper pharmaceutical products.105 However, one public health activist in Bangladesh argued that fear of counterfeiting is not reason enough to shut the door to opportunities; rather, counterfeiting can be prevented if the proper steps are taken.106 She further remarked that in the absence of parallel imports, a monopoly will result and may threaten the adequate supply of and access to affordable pharmaceuticals.107

  • 108 See Esther M. Flesch et al., Report Q 156 in the name of the Brazilian Group: International Exhaust (...)
  • 109 2005 Patent (Amendment) Act, No. 15 § 92(1), 2005 (India).

51The PDA of Bangladesh does not contain any provisions dealing with the legality or otherwise of parallel imports. Brazilian patent law does not support international exhaustion either.108 However, the Indian Patent Act, 2005 (under section 107) allows parallel imports and permits the import of patented drugs at the lowest available price in the global market (international exhaustion). Section 107A(b) of the Indian Patent Act, 2005 provides that “Importation of patented products by any person from a person who is duly authorised under the law to produce and sell or distribute the product, shall not be considered as an infringement of patent rights”.109

52The Draft PDA of Bangladesh, section 92 includes the following provision:

53Meaning of Use of Invention for Purposes of Government

  1. For the purposes of this chapter, an invention is said to be used for the purposes of government if it is made, used, exercised or vended for the purposes of the government or a government undertaking.

  2. Without prejudice to the generality of the provisions of sub-section (1) of this Section :

    1. the importation, by or on behalf of the government, of any invention being a machine, apparatus or other article covered by a patent granted before the commencement of this Act, for the purposes merely of its own use; and

    2. the importation, by or on behalf of the government, of any invention being a medicine or drug covered by a patent granted before the commencement of this Act:

      1. for the purpose merely of its own use; or

        • 110 Draft Patent and Designs Act, 2010 § 92, 2010 (Bangl.).

        for the purpose of distribution in any dispensary, hospital or other medical institution maintained by or on behalf of the government or in any other dispensary, hospital or other medical institution that the government may, having regard to the public service that such other dispensary, hospital or medical institution render, specify in this behalf by notification in the Official Gazette, shall also be deemed, for the purposes of this Chapter, to be use of such invention for the purposes of Government.110

  • 111 Draft Patent Ain (Law), 2012 § 31, 2012 (Bangl.).

54Draft Patent Ain (Law), 2012 of Bangladesh also includes a similar provision, which authorised individuals to parallel import with permission from a duly empowered authority, provided the individuals comply with the rules framed for such authorisation.111

This provision is ambiguous and only allows government institutions and duly authorised institutions or individuals to make use of parallel imports. The existing Patent Act of Bangladesh (the PDA 1911) and the Draft PDA require notification from a duly empowered authority or government, whereas the Draft Patent Law, 2012 requires compliance with clumsy administrative rules for obtaining permission for parallel imports. Considering the bureaucratic hurdles and delayed procedures typically faced when making a notification or obtaining an authorisation, along with the fact of dysfunctional government health services, this provision will have no positive effect on the availability or accessibility of cheaper generic drugs in Bangladesh. Therefore, Bangladesh should permit parallel importing by anyone, based on the principle of international exhaustion, and should adopt clear and transparent procedures for granting parallel imports within a reasonable time.

  • 112 2005 Patent (Amendment) Act § 107A(b), 2005 (India).
  • 113 ‘TRIPS, Patents and Parallel Imports’, pp. 66–74.
  • 114 See TRIPS Agreement, art. 28.1 (stating in a pertinent part that “a patent owner shall have the exc (...)

55The Indian parallel imports regime has some defects; for example, the “importation of patented products by any person from any person who is duly authorised under the law to produce and sell or distribute the product”.112 Therefore, it may restrict the importation of cheaper drugs unless the exporter is duly authorised by law to produce, sell or distribute such drugs. Shamnad Basheer explains this problem using an example: suppose India’s patent laws prohibit production of a drug that is under a valid patent, but Bangladesh’s laws do not. These drugs are available via import from a Bangladeshi drug producer because there is no pharmaceutical patent in Bangladesh; therefore, the drug producer in Bangladesh does not need any authorisation from the patent holder.113 However, under the existing provision in India, an Indian importer may be barred from importing from Bangladesh because of a potential violation of Article 28 of the TRIPS Agreement,114 as the goods produced in Bangladesh by a third party did not have authorisation from the patent holder, were not distributed by the patent holder and the patent right has not been exhausted. In this situation, there will be complications when trying to import drugs from cheaper sources that may also trigger unnecessary legal hurdles and litigation for violation of the TRIPS provisions. Therefore, Basheer suggests the following amendment be included as section 107B in India’s Patent Act, 2005:

56107B. Exhaustion of Rights

    • 115 ‘TRIPS, Patents and Parallel Imports’, pp. 84–85.

    For the purposes of this Act, the rights of a patentee or anyone claiming through such patentee shall be exhausted after a patented article has been sold once anywhere in the world (including within India), by or with the authorization of such patentee.115

  • 116 “Exhaustion of rights, or the doctrine of first sale, is inherent to IPRs and a necessity in bringi (...)
  • 117 See Krithpaka Boonfueng, ‘Parallel Imports in Pharmaceuticals: Increase Access to HIV Drugs’, Thail (...)

57This suggestion seems to be more logical because the first sale116 of a product anywhere in the world by the patent holder would be considered an exhaustion of rights, and therefore it could be imported from anyone and from anywhere in the world. Bangladesh should use this approach when drafting its parallel importation to ensure access to medicine at the best possible price. Allowing for the parallel import of pharmaceuticals may be an effective tool to force patent holders to sell their protected pharmaceuticals at reasonable and affordable prices.117

58In addition to research exceptions and parallel imports, a strong compulsory licensing regime is important for ensuring access to affordable medicines.

4.2.7 Strong Compulsory Licensing Mechanism

  • 118 ‘The South Africa AIDS Controversy’, p. 12; see also WHA Executive Board Res., WHO, ‘Revised Drug S (...)

59The issues of compulsory licensing were “brought to the forefront of the international debate about intellectual property and public health policy in January 1998, after the Executive Board of the World Health Assembly adopted a resolution urging the member states to put public health above commercial interests and to review their options under TRIPS to safeguard access to essential drugs”.118

  • 119 TRIPS Agreement, art. 31.
  • 120 Doha Declaration, at 5(b).

60Although the TRIPS Agreement does not use the term “compulsory license”, Article 31 of TRIPS permits “use without authorization of the right holder” and includes both use by third parties and the government.119 The Doha Declaration clarified the WTO’s position on compulsory licensing by providing that “each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted”.120

61Article 31 of the TRIPS Agreement dealing with compulsory licensing does not clarify the grounds on which a compulsory license can be given. However, as stated elsewhere:

  • 121 ‘Intellectual Property Protection for the Pharmaceuticals’; TRIPS Agreement, art. 31.

[C]ertain conditions listed in the Article will have to be satisfied. These include: (i) that authorization of such use will have to be considered on its individual merits, (ii) that before permitting such use (except in such cases as situations of national emergencies, extreme urgency, public non-commercial use), the proposed user will have to make efforts over a reasonable period of time to get a voluntary license on reasonable commercial terms, (iii) that the legal validity of the compulsory licensing decision and the remuneration will be subject to judicial or other independent review, and (iv) that the compulsory licenses can be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur.121

  • 122 ‘TRIPS and Pharmaceutical Industry in Bangladesh’, p. 36.
  • 123 Ibid.
  • 124 Ibid. (quoting TRIPS Agreement, art. 31). For details, see Swarup Kumar, ‘Compulsory Licensing Prov (...)

62Nevertheless, there are some “[l]ess controversial grounds for issuing compulsory licences as contemplated in TRIPS itself”, such as “[t]o correct anticompetitive practices … [n]ational emergenc[ies] or other situations of extreme urgency, including public health crises, and … [p] ublic non-commercial use, such as to provide health care to the poor”.122 In all these circumstances, “TRIPS Article 31 permits a Member to grant compulsory licences without first having to make efforts to obtain a licence from the patent owner [under] reasonable commercial terms and conditions”.123 However, even in these cases the TRIPS Agreement requires the payment of “adequate remuneration in the circumstances of each case, taking into account the economic value of the [licence]”.124 In the PDA of Bangladesh, there is also a provision dealing with the issue of compulsory licenses. Section 22 of the PDA provides that:

  1. Any person interested may present a petition to the government which shall be left at the Department of Patents, Designs and Trade Marks, together with the prescribed fee, alleging that the demand for a patented article in Bangladesh is not being met to an adequate extent and on reasonable terms and praying for the grant of a compulsory license, or, in the alternative, for the revocation of the patent.

    • 125 The PDA § 22, 1911 (Bangl.) (emphasis added).

    The government shall consider the petition, and if the parties do not come to an arrangement between themselves the government may, as it thinks fit either dispose of the petition itself or refer it to the High Court Division for a decision [author’s emphasis].125

  • 126 See generally F.M. Scherer and Jayashree Watal, ‘Post-TRIPS Options for Access to Patented Medicine (...)
  • 127 The PDA § 23(3), 1911 (Bangl.).
  • 128 Interview with a deputy registrar from the DPDT, in Dhaka, Bangladesh, 7 March 2012.

63There are some limitations within section 22 (see the passages in bold above) in the context of meeting the needs of the local pharmaceutical industry and in ensuring access to medicine. The first limitation is that the section only applies where a situation is one of inadequacy and unreasonable terms. These terms are not defined in the PDA, so there is uncertainty as to their scope. The second limitation is that there is no expert body to deal with a compulsory license application; there is only a referral to the High Court Division. The third limitation is that the section only applies to domestic need. Therefore, local generic producers in Bangladesh may not take the opportunity to export to countries that have no manufacturing capacity or those in extreme need of pharmaceuticals. The fourth limitation is that the section does not provide any clear indication as to royalties or a ceiling on the royalties in the case of a compulsory license. The absence of a clear provision on royalties may give rise to higher claims for royalties and related litigation,126 which could arguably create a degree of uncertainty. The fifth limitation is that the section does not prescribe any time limit for the conclusion of the proceedings. The sixth limitation is that the section does not provide that a compulsory license can be issued on the grounds of public interest, a health emergency or for public non- commercial use. Further, section 23(3) of the PDA states that “No order revoking a patent shall be made … which is at variance with any treaty, convention, arrangement or engagement with any foreign country”.127 Such a provision could be used to prevent the issue of a compulsory license or the revocation of a patent, facilitating the argument that Bangladesh is breaching the TRIPS Agreement or any other bilateral free trade and investment agreement. Thus, patent holders could take advantage of the cumbersome procedure and frustrate the efforts of interested enterprises in getting compulsory licenses. Despite having provisions for compulsory licenses, the Government of Bangladesh has never issued a compulsory license for patented drugs.128

  • 129 See generally ‘The Use of Flexibilities in TRIPS by Developing Countries’.

64These limitations should be removed and the PDA amended to incorporate a viable compulsory licensing mechanism. In this regard, the legislative examples of India and Brazil may be useful. Both countries have included compulsory licensing mechanisms within their legislative regimes. Such legislation has the potential to not only ensure access to medicines, but also enable local generic producers to export and supply generic pharmaceuticals to other poor countries, countries without manufacturing capacity and those in urgent need of medicines.129

65Bangladesh should adopt a provision similar to the Indian provision that permits the issue of a compulsory license in the case of a national emergency or health crisis, or for public non-commercial use. For example, section 92(1) of the Indian Patent Act, 2005 provides that:

664.2.1

  • 130 2005 Patent (Amendment) Act § 92(1), 2005 (India).

If the Central Government is satisfied, in respect of any patent in force, in circumstances of national emergency or in circumstances of extreme urgency or in case of public non-commercial use, that it is necessary that compulsory licences should be granted at any time after the sealing thereof to work the invention, it may make a declaration to the effect, by notification in the Official Gazette.130

67To allow exports under a compulsory license, section 92A of the Indian Patent Act, 2005 states:

    • 131 Ibid., § 92A (emphasis added).

    Compulsory licenses shall be available for the manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public-health problems, provided compulsory licences have been granted by such country or such country has, by notification or otherwise, allowed importation of the patented pharmaceutical products from India [author’s emphasis].131

68Bangladesh should adopt a similar provision to allow local generic producers to exploit the opportunity to export cheap generic medicines to other countries that have no manufacturing capacity or that are facing an extreme health emergency. It is also interesting to note that the Indian Patent Act, 2005 includes a provision listing the prime objectives for granting a patent for pharmaceuticals. In the event of a violation of any of these provisions, grounds for the issue of a compulsory license could be raised. In this regard, section 83 of that Act provides:

69Without prejudice to the other provisions contained in this Act, in exercising the powers conferred by this Chapter, regard shall be had to the following general considerations, namely:

  1. that patents are granted to encourage inventions and to secure the Public-health Safeguards in Indian Patents Act that the inventions are worked in India on a commercial scale and to the fullest extent that is reasonably practicable without undue delay;

  2. that they are not granted merely to enable patentees to enjoy a monopoly for the importation of the patented article;

  3. that the protection and enforcement of patent rights contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations;

  4. that patents granted do not impede protection of public health and nutrition and should act as instruments to promote public interest, especially in sectors that are of vital importance for the socioeconomic and technological development of India;

  5. that patents granted do not in any way prohibit Central Government in taking measures to protect public health;

  6. that the patent right is not abused by the patentee or person deriving title or interest on-patent from the patentee, and the patentee or a person deriving title or interest on-patent from the patentee does not resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology; and

    • 132 Ibid., § 83 (emphasis added).

    that patents are granted to make the benefit of the patented invention available at reasonably affordable prices to the public [author’s emphasis].132

  • 133 TRIPS Agreement, arts. 7–8.

70By inserting the above section, the Indian government validated its present actions and any future actions as a measure to protect the public interest. In particular, sections 83(d) and (e) are adopted from the objectives and principle clause of the TRIPS Agreement,133 which validates government actions based on the socioeconomic conditions of the country. Bangladesh should adopt a similar provision as a proactive measure so that it can validate future actions to protect the public interest, and the socioeconomic interest and developmental goals of the country.

  • 134 ‘Product Patents and Access to Medicines in India’, pp. 326, 341.

71However, commentary on the Indian compulsory licensing regime has highlighted a limitation of the section: there is no clear detail regarding the requirement to pay royalties. Gopakumar states that “gaps in the law take away the effectiveness of a compulsory license regime under the Patents Act. As a result, during the last five years only one application was filed for the issuance of a compulsory license in India”.134

  • 135 Lei No.9.279 art. 71, de 14 de maio de 1996, Diario Oficial Da Uniao [DOU] de 15.05.1996. (Braz.), (...)

72In this respect, either an administrative body should be created to speed up the process of issuing compulsory licenses in the case of an emergency situation, or a provision should be enacted to empower the government itself to issue a compulsory license without application. In this respect, Article 71 of the Brazilian Industrial Property Law provides that “In cases of national emergency or of public interest, as declared in an act of the Federal Executive Power, and provided the patent holder or his licensee does not fulfil such need, a temporary and non-exclusive compulsory license for exploiting the patent may be granted, ex officio, without prejudice to the rights of the respective titleholder”.135

  • 136 Brazil used this provision to threaten compulsory licenses to gain substantial price reductions on (...)
  • 137 Draft Patents and Design Act, 2010, § 84, 2010 (Bangl.).
  • 138 Although it is not clarified in the Draft Patents and Design Act, 2010, the Draft Patent Ain, 2012 (...)

73This provision empowers the Brazilian government to issue a compulsory license if negotiations between parties fail.136 Such a legislative option should be considered by Bangladesh as part of its TRIPS-compliant legislative regime. In the Draft PDA, Bangladesh tried to use the Indian option, but the provision needs clarification137 because it is not clear whether exports can be made to non-WTO member countries and to those that do not have pharmaceutical patents or patents of a particular drug.138 As the law currently stands, the issue of compulsory licenses is still determined by the courts, as in India, rather than by any specific executive body, as in Brazil. The court procedure in Bangladesh is overly long, costly and complicated; thus, it may discourage potential applicants from applying for compulsory licenses.

  • 139 ‘Integrating Intellectual Property Rights’, p. 8.
  • 140 CIPIH Report, p. 176.

74In this regard, the IPR Commission in the UK has stated that “an important barrier to compulsory licensing in developing countries is the absence of straightforward legislative and administrative procedures to put it into effect”.139 In addition, the CIPIH Report recommends that “Countries should provide in their legislation powers to use compulsory licensing, in accordance with the TRIPS agreement, where this power might be useful as one of the means available to promote, inter alia, research that is directly relevant to the specific health problems of developing countries”.140

75Bangladesh should follow the Brazilian approach of issuing compulsory licenses and establish an expert body to deal with compulsory licensing issues in the shortest possible time, speeding up the production of generic drugs in cases of public health crises. As the TRIPS Agreement does not prohibit administrative decision-making on compulsory licenses and government use of patents, the establishment of an expert administrative body could speed up the issue of compulsory licenses and also avoid prolonged litigation, as the legal systems in most developing countries and LDCs, including Bangladesh, are already overburdened.

  • 141 “The Human Development Index (HDI) is a measure of life expectancy, literacy, education, and standa (...)
  • 142 According to James Love: In 2005, Canada proposed royalty guidelines for the export of medicines un (...)
  • 143 The ranking of Bangladesh in the HDI of 2010 was 129. UNDP, ‘Human Development Report 2010, The Rea (...)

76Further, the issue of reasonable remuneration is not clearly defined; bargaining over this issue may also unnecessarily delay the procedure of issuing compulsory licenses. In this case, Bangladesh could perhaps adopt, with slight modification, the Canadian approach of fixing royalties based on the UN’s Human Development Index (HDI).141 The same formula should be used based on the ranking of the country in which the manufactured drugs under the compulsory license are to be exploited (the Canadian model only accounts for exports based on the destination of the drugs—the importing country).142 Bangladesh still holds a very low ranking in the HDI, and most of the exporting destinations of Bangladeshi pharmaceutical products are also in the lower levels of the HDI.143 With this modification, Bangladesh would be able to produce drugs locally using compulsory licenses, or it could use compulsory licenses for export by paying the minimum fixed royalties without any cumbersome bargaining.

77Further, the Government of Bangladesh may need to modify existing provisions that regulate “local working” of the patent or related provisions concerning patented processes or products used or manufactured outside of Bangladesh. Section 23 of the PDA provides that:

  1. At any time not less than four years after the date of a patent granted under this Act, any person may apply to the Government for relief under this section on the ground that the patented article or process is manufactured or carried on exclusively or mainly outside Bangladesh.

  2. The Government shall consider the application, and, if after inquiry it is satisfied-

    1. that the allegations contained therein are correct; and

    2. that the applicant is prepared, and is in a position, to manufacture or carry on the patented article or process in Bangladesh; and

    3. that the patentee refuses to grant a license on reasonable terms, then, subject to the provisions of this section, and unless the patentee proves that the patented article or process is manufactured or carried on to an adequate extent in Bangladesh, or gives satisfactory reasons why the article or process is not so manufactured or carried on, the Government may make an order; and

      • 144 The PDA § 23, 1911 (Bangl.).

      revoking the patent144

  • 145 Ibid.
  • 146 2005 Patent (Amendment) Act § 84, 2005 (India): Compulsory licences. –
    (1) At any time after the exp
    (...)
  • 147 Lei No.9.279 art.68, de 14 de maio de 1996, Diario Oficial Da Uniao [DOU] de 15.05.1996. (Braz.), t (...)
  • 148 See generally ‘India, the Pharmaceutical Industry and the Validity of TRIPS’; see also Daya Shanker (...)

78The existing patent law of Bangladesh does not contain any definition of the clause “manufactured or carried on exclusively or mainly outside Bangladesh” as articulated in section 23 of the PDA. This absence of a definition may result in varied and ambiguous interpretations. Again, section 23 of the PDA requires that four years should lapse from the date of granting of a patent before one can apply for its revocation on the grounds of “non-working in the territory” of Bangladesh.145 Therefore, the ambiguity of the existing provision and the four-year requirement will delay the entry of cheaper local pharmaceuticals. This will allow the MNPCs to enjoy a monopoly for their patented pharmaceuticals without any transfer of technology and investment for local manufacture, since they will rely on manufacturing facilities outside Bangladesh. In this regard, section 84 of the Indian Patent Act, 2005146 and Article 68 of the Brazilian Industrial Property Act, 1996147 may be models for Bangladesh, because so far they have successfully resisted the pressure of the US and the MNPCs.148

  • 149 Compulsory License Application No. 1 of 2011, Application for Compulsory License Under Section 84(1 (...)
  • 150 Ibid., pp. 39–45.
  • 151 Ibid., p. 43.

79The Indian Controller of Patents, while disposing of an application for compulsory license in Natco Pharma Ltd. v. Bayer Corp.,149 clarified the issue of the working of the patent in the territory of India. The controller noted that the term “worked in the territory of India” had not been defined in the Indian Patent Act, 2005, and so he needed to interpret the term with regard to “various International Conventions and Agreements in intellectual property”, the Patent Act, 1970 and the legislative history.150 The controller, using Article 27(1) of the TRIPS Agreement and Article 5(1)(A) of the Paris Convention, interpreted it to mean that failure to manufacture in India supported the grant of a compulsory license to Natco, stating that: “[p]atents are not granted merely to enable patentees to enjoy a monopoly for importation of the patented article” and that “the grant of a patent right must contribute to the promotion of technological innovation and to the transfer and dissemination of technology”.151

80Therefore, considering the experience of India, the author consider that Government of Bangladesh could adopt the following provision on the working of the patent in the territory of Bangladesh:

Compulsory License for Non-working in the territory of Bangladesh: At any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Department of Patents, Designs and Trademarks or to the duly authorised office for grant of a compulsory license on patent on any of the following grounds, namely –

1) that the reasonable requirements of the public with respect to the patented invention have not been satisfied…

2) the demand for the patented article has not been met to an adequate extent or on reasonable terms…

3) that the patented invention is not available to the public at a reasonably affordable price

4) that the patented invention is not worked in the territory of Bangladesh.

81This section is to be applied to the extent that due consideration is given to the fact that patents are not granted merely to enable patentees to enjoy a monopoly on importation of the patented article: the grant of a patent right must contribute to the promotion of technological innovation and to the transfer and dissemination of technology.

  • 152 During interviews, compulsory licensing was supported by most of the executives of local pharmaceut (...)
  • 153 Interview with a policy analyst from an MNPC operating in Bangladesh, in Dhaka, Bangladesh, 9 March (...)
  • 154 Interview with a policy analyst from an international NGO working in Bangladesh, in Dhaka, Banglade (...)

82During interviews, most participants argued that Bangladesh should have strong compulsory licensing mechanisms.152 However, one participant argued that compulsory licenses are not a viable option as they will discourage technology transfer and FDI in Bangladesh.153 Another participant commented that the provision alone would not be enough if the procedure was complicated and resulted in an inordinate delay in the issuance of compulsory licenses.154 Including a compulsory license provision in its future amended patent law that avoids clumsy and complicated procedures will help Bangladesh ensure access to pharmaceuticals in the event of a public health emergency and provide a competitive advantage to its local pharmaceutical industry when exporting to countries that have low or no manufacturing capacity.

83Similarly, Bangladesh should include a prior use exception to protect local producers within the pharmaceutical industry.

4.2.8 Prior Use Exceptions

  • 155 ‘Public and Private Sector Approaches’.

84Given the number of local generic producers in Bangladesh and the magnitude of investment made in the area of cheap generics, the prior use exception should be incorporated into Bangladesh’s TRIPS- compliant patent law. In a study by the World Bank, the Indian example of prior user rights is referred to as a “grandfather clause” or automatic compulsory license and described as follows: “Generic versions of patented medicine can continue to be manufactured in India provided that: (1) the generic manufacturer was producing and marketing the product prior to January 1, 2005; (2) the generic manufacturer made significant investment in the production and marketing for the product; and, (3) a reasonable royalty is paid to the patent holder”.155

  • 156 This was mentioned by representatives from a number of large, medium and small pharmaceutical compa (...)
  • 157 Interview with the CEO of an MNPC operating in Bangladesh, in Dhaka, Bangladesh, 9 March 2012.

85During the author’s field studies in Bangladesh, the majority of participants strongly supported the inclusion of a prior use rights provision similar to India’s.156 However, one participant argued that this kind of provision would discourage FDI and transfer of technology to Bangladesh.157

  • 158 Lei No.9.279 art. 45, de 14 de maio de 1996, Diario Oficial Da Uniao [DOU] de 15.05.1996. (Braz.), (...)

86The Indian example of prior user rights has some weaknesses. It may be challenged by the patent holder on a number of grounds. If it was not exploited prior to 1 January 2005, or prior to the introduction of pharmaceutical patents, investment alone is not sufficient (as there is no indication in the law), and the degree of investment that can be considered sufficient, as well as the reasonable royalty rate, may be challenged. These weaknesses may create barriers for generic production. In this case, Bangladesh should perhaps replicate the Brazilian provision, which has no such limitations. Such an exception is contained in Article 45 of Brazil’s Industrial Property Law and provides that “A person who in good faith, prior to the filing or priority date of a patent application, was exploiting the object thereof in this country, shall be assured the right to continue the exploitation, without onus, in the same manner and under the same conditions as before”.158

87Although the above legislative options help define the matters of patentability and exceptions, a provision related to the patent application objection procedure should also be included.

4.2.9 Pre-grant and Post-grant Opposition

  • 159 ‘Pharmaceutical Patent Protection’, pp. 1, 8.

88Pre-grant and post-grant opposition “is an important way to assist and encourage public interest groups and local generic pharmaceutical companies to oppose attempts by others” who seek patents.159 An opposition provision is currently contained in section 9(1) of the PDA:

  • 160 The PDA § 9(1)), 1911 (Bangl.) (emphasis added).

Any person may, on payment of the prescribed fee, at any time within four months from the date of the advertisement of the acceptance of an application, give notice at the Department of Patents, Designs and Trade Marks of opposition to the grant of the patent on any of the following grounds, namely:
1) that the applicant obtained the invention from him, or from a person of whom he is the legal representative or assign; or
2) that the invention has been claimed in any specification filed in Bangladesh which is or will be of prior date to the patent, the grant of which is opposed; or
3) that the nature of the invention or the manner in which it is to be performed is not sufficiently or fairly described and ascertained in the specifications; or
4) that the invention has been publicly used in any part of Bangladesh or has been made publicly known in any part of Bangladesh; or
5) that the complete specification describes or claims an invention other than that described in the provisional specification, and that such other invention either forms the subject of an application made by the opponent for a patent, which if granted would bear a date in the interval between the date of the application and the leaving of the complete specification, or has been made available to the public by publication in any document published in Bangladesh in that interval;
but on no other ground [author’s emphasis].160

  • 161 Azam and Richardson (2010a), p. 8.
  • 162 Ibid.
  • 163 Ibid.
  • 164 Ibid., 8.

89As emphasised above and in a study by Azam and Richardson, objections to the provision are limited by two conditions. The first is that “the objection must be made within four months of the advertisement of the acceptance of the application”.161 The second is that the objection can only be based on the grounds provided by section 9(1).162 Azam and Richardson further state that “[i]f defects in the patent application are revealed, or identified after the four-month period, no objection can be raised against the patent application. In other words, the existing legislative regime does not permit any type of post-grant opposition”.163 They add that “This is in contrast to the legislative equivalent in India which not only contains eleven grounds for pre-grant opposition but also permits post-grant opposition”.164

  • 165 Ibid.; see also The Patent Opposition System in India, p. 14.

90The Indian grounds for post-grant opposition are “broad enough to challenge novelty, inventive steps and the process of industrial application, best method, claims and disclosure of origin and even the use of indigenous or local knowledge”.165 Given this comparison, it is clear that the existing Bangladeshi provision is not sufficient and should be amended to include more extensive pre-grant heads of objection, as well as a process for post-grant opposition.

  • 166 Azam and Richardson (2010a), pp. 8–9.
  • 167 During interviews, this view was echoed by most of the officials of pharmaceutical companies in Ban (...)
  • 168 Interview with an IP academic from the University of Chittagong, in Chittagong, Bangladesh, 5 March (...)
  • 169 Ibid.
  • 170 Interview with the CEO of an MNPC operating in Bangladesh, in Dhaka, Bangladesh, 7 March 2012.

91In taking such a legislative step, Bangladesh should ensure “that the heads of objection should be as wide as possible so that the twin aims of ensuring access to medicine with the aim of promoting innovation within the pharmaceutical industry are not hampered”.166 During the author’s field studies in Bangladesh, the majority of participants opined that the Indian example of pre-grant and post-grant opposition would need to be replicated in Bangladesh.167 However, one participant argued that the local pharmaceutical industry and public health organisations in Bangladesh lack adequate expertise and resources to effectively exploit pre-grant and post-grant opposition; they should prepare themselves to use this option effectively.168 Another participant also criticised the lack of accessible online information about ongoing patent applications in Bangladesh and the fact that even a paper copy of DPDT’s journal is not distributed regularly. This means that interested parties will have extreme difficulties in collecting the required information to oppose any patent application or granted patent.169 Therefore, simply including this provision may not be enough unless access to information regarding patent applications and granted patents is regularly updated and available for review by interested parties. One interviewee, however, argued that this provision may open the flood gates to unnecessary opposition and may even frustrate investment in the pharmaceutical sector.170

92The issue of how long a patent should last also needs consideration.

4.2.10 Duration of Patent Protection

  • 171 Lei No.9.279 art. 40, de 14 de maio de 1996, Diario Oficial Da Uniao [DOU] de 15.05.1996. (Braz.), (...)

93Under section 14 of the PDA of Bangladesh, patent protection is available for 16 years. The TRIPS Agreement requires that patent protection be available for 20 years. The Brazilian Industrial Property Law simply indicates that patent protection shall be for 20 years from the date of filing.171 Indian patent law extends the duration to 20 years subject to patent legislation in India, and states that the duration is to be counted from the date of filing:

  • 172 2005 Patent (Amendment) Act, § 53(1), 2005 (India).

Subject to the provisions of this Act, the term of every patent granted, after the commencement of the Patents (Amendment) Act, 2002, and the term of every patent which has not expired and has not ceased to have effect, on the date of such commencement, under this Act, shall be twenty years from the date of filing of the application for the patent.172

  • 173 From interview data (this has been supported by many large, medium and small local pharmaceutical c (...)
  • 174 Interview with an executive from an MNPC operating in Bangladesh, in Dhaka, Bangladesh, 9 March 201 (...)

94Although the TRIPS Agreement limits the ability of Bangladesh to explicitly reduce a patent period, the legislative amendment should contain a qualification. To that extent, this study suggests that while amending the PDA to be TRIPS-compliant, Bangladesh could add that the “duration of protection is subject to exceptions as included in this Act or to be included by any future amendments”. Such an extension may provide the government with some freedom to act as times change and TRIPS compliance is assessed. It will also permit the government to act immediately in case of a health emergency or the public interest. During interviews, some participants considered this kind of reservation to be useful in limiting patent protection, if necessary, on public interest grounds.173 However, one participant argued that limiting patent protection will discourage investment in the pharmaceutical sector; he argued instead that 20 years is not sufficient to recover investment and that the duration should be extended to 30 years in the pharmaceutical sector.174

  • 175 See Emily Jones, ‘Signing Away the Future: How Trade and Investment Agreements Between Rich and Poo (...)
  • 176 Ibid.
  • 177 El Said (2010), p. 145.

95The US and the EU (driven and supported by their MNPCs), while negotiating bilateral investment agreements with the developing countries and the LDCs including Bangladesh, insisted on the inclusion of an extended period for pharmaceutical patents beyond 20 years to compensate the originator of the drug for the time lost during the patent application and drug registration procedures.175 The US and the EU considered this a legitimate right that should be granted to “compensate” their pharmaceutical companies for “unreasonable” delays throughout the patent examination or registration processes.176 However, “[t]he costs of patent term extension are grave”.177 For example:

  • 178 Ibid.; see also ‘US FTA May Cost Drug Industry $ 1.2 Billion: Gov’t’, the hankyoreh, 17 October 200 (...)

a recent study in the Republic of Korea concluded that the extension of patent terms is likely to cost the Korean National Health Insurance Corporation … 504.5 billion won (US$ 529 million) for extending drug patents for three years and 722.5 billion won (US$ 757 million) if it has to agree to a four-year extension as proposed under [Free Trade Agreement] negotiations with the US.178

  • 179 El Said, p. 144; see ‘Resource Book on TRIPS and Development’. It should be noted that patent term (...)

96The TRIPS Agreement “is clear regarding this term of protection. It does not specify that a member state is obliged to extend the patent protection term for any reason (including delays in registering drugs or issuing patents) beyond the term prescribed under Article 33”.179

  • 180 CIPIH Report, p. 182.

97In this regard, the CIPIH Report states that “[b]ilateral trade agreements should not seek to incorporate TRIPS-plus protection in ways that may reduce access to medicines in developing countries”.180

98Therefore, LDCs such as Bangladesh should not adopt patent term extensions under the patent regime and should not agree in any future free trade agreements (FTAs) to patent terms beyond the TRIPS Agreement. Again, the Government of Bangladesh needs to craft enforcement provisions in such a way as not to erect barriers to the production and supply of generic drugs.

4.2.11 Do Not Adopt Overprotective Enforcement Provisions

  • 181 See generally ‘Global Communication on HIV and the Law, Regional Issues Brief: Intellectual Propert (...)
  • 182 See generally Ermias Biadgleng and Viviana Tellez, ‘The Changing Structure and Governance of Intell (...)
  • 183 See generally Carlos Correa, Centre for Interdisciplinary Studies on Industrial Property and Econom (...)
  • 184 UNDP, p. 46.

99LDCs such as Bangladesh should be aware that the TRIPS Agreement only sets minimum requirements with respect to the enforcement of IPRs. However, there has been an increased focus on strengthening mechanisms for the enforcement of IPRs, far beyond what is required by the TRIPS Agreement, through so-called “anti-counterfeiting” initiatives.181 The developing countries and LDCs are increasingly under pressure to place criminal sanctions on a wide array of IPR violations, including patent infringement.182 However, placing criminal sanctions on patent infringement (e.g., considering generic medicines “counterfeit”)183 can restrict access to medicines and “could have a chilling effect on generic manufacturers’ willingness to enter the market with affordably priced generic medicines”.184

  • 185 Ibid.; see Henning Grosse Ruse-Khan and Thomas Jaeger, ‘Policing Patents Worldwide? EC Border Measu (...)
  • 186 UNITAID is the first global health organisation that “uses innovative financing to increase funding (...)
  • 187 See Frederick M. Abbott, ‘Seizure of Generic Pharmaceuticals in Transit Based on Allegations of Pat (...)

100On the other hand, “overbroad powers granted to customs officials, have already been used to hinder the legitimate trade of affordable generic medicines” under the pretext of counterfeiting and infringement.185 For example, in 2009, Dutch authorities seized a shipment in transit of the generic drug Abacavir, produced in India, purchased by the NGO UNITAID186 and on its way to Africa, on the grounds that the generic version of the medicine violated patent rights in Europe.187

  • 188 The International Medical Products Anti-counterfeiting Taskforce (IMPACT) is a global coalition of (...)
  • 189 For details, see ‘Access to Indian Generic Drugs: Emerging Issues’, pp. 225–52.
  • 190 See Why did the Government of India oppose the ‘counterfeit drug’ definition proposed by IMPACT?’, (...)
  • 191 See WHO, Counterfeit Drugs. Guidelines for the development of measures to combat counterfeit drugs, (...)

101The use of the term “counterfeit” medicines became more controversial when the WHO–IMPACT meeting in December 2008 suggested that a medical product is counterfeit when there is false representation in relation to its identity, history or source, or to its container, packaging or other labelling information.188 However, the 66th meeting of the WHO Regional Committee for South-East Asia rejected the WHO-IMPACT definition of counterfeit drugs. Recognising the need to separate IP issues from quality and safe medical products, the draft resolution urged member countries to refrain from IP enforcement that compromises access to medicines.189 In this regard, the Indian Pharmaceutical Alliance argued that the references to “history” and “source” in the WHO-IMPACT definition suggest patent infringement and that this might affect exports of generics (from India) because it wrongly leads the public to believe that generics are counterfeits.190 Therefore, India requested that the original WHO definition of counterfeit medicines be maintained: “A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging”.191

  • 192 See TRIPS Agreement, art. 61. It states: Members shall provide for criminal procedures and penaltie (...)

102However, the TRIPS Agreement does not require the criminalisation of patent infringement, and it limits criminalisation obligations to wilful trademark counterfeiting and copyright piracy on a commercial scale.192 Neither Brazil nor India has adopted overprotective enforcement mechanisms that could criminalise generic production and supply. Therefore, while instituting TRIPS-compliant enforcement obligations within domestic patent law and pharmaceutical regulations, the Government of Bangladesh, rather than adopting overprotective provisions that would hamper the supply of generic medicines, should focus on efforts to strengthen drug regulatory authorities; promote rational use and encourage the public not to sell, buy or distribute any fake or counterfeit medicines; and should not include ‘patent infringement’ as a possible ground under the term of ‘counterfeiting of medicines’.

103In addition to the above legislative options, the Government of Bangladesh should consider additional interventions to ensure access to medicines and to promote pharmaceutical innovation in the process of moving towards a TRIPS-compliant regime.

4.3 Government Intervention Options

  • 193 See ‘Access to HIV/AIDS Treatment in Developing Countries’, Interagency Coalition on AIDS and Devel (...)
  • 194 Interview with officials at the DGDA and public health NGOs, in Dhaka, Bangladesh, 12–15 March 2012
  • 195 Make Vital Medicine Available for People, p. 5.

104Although the patenting of pharmaceuticals and the consequent effect on pharmaceutical price do not constitute the only issue affecting access, it is considered a significant barrier and one that is common to all developing countries, whatever their stage of development.193 Most interviewees in this study echoed the belief that simply using the flexibilities available in the TRIPS Agreement when drafting national patent laws will not improve access to medicines in Bangladesh, especially when the country’s economic development, health infrastructure, drug distribution and drug availability are in disarray.194 There is also the fear that the achievements made thus far through the local production of pharmaceuticals will not continue if MNPCs and developed countries put pressure on Bangladesh to refrain from producing and exporting cheaper generic drugs that compete with the more expensive patented brands produced by the MNPCs.195

  • 196 Ibid.
  • 197 Ibid.
  • 198 Ibid.
  • 199 Quoted in Make Vital Medicine Available for People.
  • 200 Email interview with a patent law academic, in New Delhi, India, 11 March 2012.

105Nonetheless, MNPCs and developed countries are not yet pressuring Bangladesh for pharmaceutical patents. As an LDC, Bangladesh can still waive compliance with the pharmaceutical patents of the TRIPS Agreement. Additionally, Bangladesh is not yet a competitive threat because it is not a country that promises huge profits.196 Despite its population of more than 150 million people, the average wage, life expectancy and literacy rate are among the lowest in the world, and its local pharmaceutical industry is incapable of making the raw materials for new drugs; hence, MNPCs are not interested in putting pressure on Bangladesh.197 In 1997, the US Embassy in Bangladesh reported that “Intellectual property infringement is common, but is currently of relatively limited significance for US firms”.198 One study suggested that “this attitude may change soon, as it has happened in other poor countries such as Ghana and Uganda where multinational companies have already acted to stop them importing cheaper generic drugs, which compete with the more expensive patented brands of medicine”.199 Therefore, apart from reforming patent law, Bangladesh may need to consider other alternative government intervention options to ensure access to medicines.200

106Supporting alternative measures to market-based instruments, Zafarullah Chowdhury remarks that:

  • 201 Make Vital Medicine Available for People, p. 6.

Medicines are one commodity you can’t leave to market forces. The market is simply not competent. It makes for monopolies and cartels, not competition. And every drug is, by definition, essential. If you have a malfunctioning liver and only one drug can save your life, that to you is the most essential drug in the world. Allowing the global drug market to be controlled by foreign firms (with lengthy periods of patent control) is not going to help us.201

  • 202 Ibid.

107Chowdhury further adds that “local drug firms have no innovative technology, therefore when Bangladesh is bound to honor foreign patents on new drugs that could be our collapse”.202

  • 203 Ibid.

108Another renowned public health activist in Bangladesh, Farhad Mazahar, remarks that “the impact of pharmaceutical patent on Bangladesh will be huge because most of our raw materials [for new and existing drugs] come from India and our companies are only pharmacies, really [not a pharmaceutical industry]”.203 Therefore, considering the delicate state of public health infrastructure, the low level of access to medicines and lack of innovation in its local pharmaceutical industry, Bangladesh should adopt some alternative measures based on the examples of Brazil, India and South Africa. These are (i) controlling drug prices; (ii) national competition law; (iii) introducing a patent prize system; (iv) limiting data protection; (v) developing a patent pool on country-specific diseases; (vi) avoiding TRIPS-plus requirements in any future Bilateral Investment Treaties (BITs) or under FTAs with developed countries, particularly the US and the EU; (vii) lobbying for a further extension to the transitional period for pharmaceutical patents; (viii) introducing process patents only for limited periods and adopting a utility model law; and (ix) instituting a special investment protection regime, open source drug innovation and a social business model in the pharmaceutical sector.

4.3.1 Drug Price Control

  • 204 See generally, World Health Organization (WHO), Drugs and Money Prices, Affordability and Cost Cont (...)
  • 205 Amit Sen Gupta, ‘Should Drug Prices be Controlled?’, Economic Times (6 August 2002), http://article (...)
  • 206 Jan Swasthya Abhiyan, National Coordination Committee, ‘Access to Essential Medicines’, p. 37 (Febr (...)
  • 207 The pharmaceutical price regulation scheme regulates profits to within 17–21% on historic capital o (...)
  • 208 See Alan Maynard and Karen Bloor, ‘Dilemmas in Regulation of the Market for Pharmaceuticals’, Healt (...)

109The affordability of medicines by individual patients in the LDCs is an important factor influencing access to care and treatment.204 However, control over the cost of medicines exists in one form or another in most countries. For example, in Australia, “new drugs with no advantage over existing products are offered at the same price”,205 and “Where clinical trials show superiority, incremental cost effectiveness is assessed to determine whether a product represents value for money at the price sought”.206 In the UK, the pharmaceutical price regulation scheme—a voluntary agreement between the Department of Health and the Association of the British Pharmaceutical Industry—exists so that companies negotiate profit rates from sales of drugs to the UK National Health Service.207 In France, Italy and Belgium, prices are set in relation to the relative cost and contribution made to the national economy.208

  • 209 See Azam and Richardson (2010b).
  • 210 See Study on the Viability of High Quality Drugs Manufacturing.

110In Bangladesh, there is no drug price control mechanism under the existing Patent Act. However, the DCO 1982 provides for the fixing of prices by a government-appointed committee.209 The committee mostly deals with essential medicines, as listed by the DGDA. Accordingly, these listed drugs can be circulated without such pricing controls.210

  • 211 No drug can be introduced into the market without prior approval from the Drug Control Committee an (...)
  • 212 DCO 1982, § 6(1) (Bangl.).

111This is an important guarantee that the prices of pharmaceuticals, whether produced nationally or imported from the outside, will not increase without prior government authorisation.211 Further, it is within the government’s purview to refuse the registration of any pharmaceuticals that are regarded as unaffordable.212

  • 213 See Study on the Viability of High Quality Drugs Manufacturing.
  • 214 Interview with an official from the DDA, in Dhaka, Bangladesh, 26 February 2012.
  • 215 See Sanjay Kathuria and Mariem Mezghenni Malouche, Toward New Sources of Competitiveness in Banglad (...)
  • 216 Ibid.

112In 1982, 150 pharmaceuticals were defined as essential pharmaceuticals213 and any changes to their prices were decided by the DCC. However, since 1993, the number of price-controlled pharmaceuticals has declined to 117 primary healthcare pharmaceuticals.214 The DCO 1982 empowered the government to determine the Minimum Retail Price (MRP) of these 117 essential drugs/chemical substances. The MRP consists of trade price (75.5%), wholesale commission (2.3%), retail commission (12.0%) and VAT (12.5%) for local products.215 The breakdown for imported products is trade price (88.9%) and retail commission (11.11%).216

  • 217 DCO 1982, § 4(2) (Bangl.).
  • 218 Interview with a policy analyst from an international public health NGO, in Dhaka, Bangladesh, 23 F (...)

113Non-essential drugs are priced through a system of indicative prices. The rule is applicable only in the case of locally produced goods. A fixed percentage of mark-up is applied to the cost and freight price of finished goods to determine the MRP of imported finished goods. This applies to both essential and non-essential products. Therefore, the manufacturer is able to set the price for pharmaceuticals that do not fall into the controlled category. In principle, this does not mean that an exorbitant price can be set by a manufacturer, as the price must be approved (but not controlled) by the DCC;217 however, in practice, the committee accepts the pricing offered by manufacturers or importers for products that are not on the list of essential medicines. No other stakeholders have a say in fixing the price.218 The result is that sometimes manufacturers or importers demand higher prices if the product is not on the essential medicines list in Bangladesh, and the DCC will not object to or criticise the pricing.

114The list needs to be updated from time to time, as some older listed medicines may not work and thus patients may need expensive new medicines that are often exempt from price control. One such situation occurs with multi-drug resistance, in which the older drugs are not working and yet the patient cannot afford the newer expensive drugs. Zaman Khan explains the situation in Bangladesh:

  • 219 Make Vital Medicine Available for People, p. 4.

we have recently lost four patients to multi-drug resistance disease. Eventually there will be new drugs but they will be even more expensive than the antibiotics we use now, Cefrazidine from Glaxo, for instance, at 450 taka (US$ 8) a dose or Ceftriazone from Roche, at 500 taka ($ 9). Very few people can even afford the drugs we have got. We ask patients about their economic history and then we decide who can and can’t afford drugs. But I would say 70% of the people we see cannot afford to buy medicines. Even the cheaper versions are often beyond them.219

115This account is corroborated by Khurshid Talukder of the Institute of Child and Mother Health in Bangladesh:

We just want the best possible answers to treat all diseases. Simply, we must have the drugs here when they are available in developed countries. And they have to be affordable for poorer people to buy.

  • 220 Ibid.

People are often too poor to buy the correct drugs needed to cure an illness or cannot complete the full course of medicines, which in turn leads to more resistance.220

  • 221 Ibid.
  • 222 Interview with public health NGOs and pharmaceutical researchers, in Dhaka, Bangladesh, 12 March 20 (...)
  • 223 Ibid.
  • 224 Interview with a public health activist, in Dhaka, Bangladesh, 23 December 2009.

116Public health activists and generic producers in Bangladesh who are concerned about the possible negative effect of TRIPS on the public health situation in Bangladesh say that “people of Bangladesh could be very seriously affected. It is an alarming and dismal picture”.221 Thus, most of the public health NGOs and experts in Bangladesh believe that the government should establish a permanent price control mechanism and make it accessible to the general public and public health groups.222 Any individual or public health group would then be permitted to challenge or review the pricing of medicines on social or health grounds.223 Another concern is the number of pharmacies that operate in Bangladesh without a license and sell pharmaceuticals to customers without a prescription and at a higher price.224

117The DCC should be given jurisdiction to deal with these issues, and public health interest groups should be able to access the committee.225 An example of a body that operates in such a fashion is the Canadian Patented Medicine Prices Review Board (PMPRB), established under the Patent Act, 1987 as an independent quasi-judicial tribunal that limits the prices set by manufacturers for all patented medicines—new and existing—sold in Canada under prescription or over the counter, thus ensuring that pricing is not excessive.226 As an independent quasi- judicial body, the PMPRB carries out its mandate independently of other organisations such as Health Canada—which approves drugs for safety and efficacy—and public drug plans, which approve the listing of drugs on their respective formularies for reimbursement purposes.227 The PMPRB has adual role in regulating and reporting.228 Its regulatory role is to protect consumers and contribute to Canadian healthcare by ensuring that prices charged by manufacturers for patented medicines are not excessive.229 Its reporting role contributes to informed decisions and policymaking by reporting on pharmaceutical trends and on the R&D spending by pharmaceutical patentees.230 The PMPRB is unique in the sense that it was set up exclusively to monitor the prices of patented drugs. In addition, it analyses the therapeutic contribution of patented pharmaceuticals and documents pharmaceutical R&D investment in Canada. A similar mechanism should be considered by Bangladesh as it moves towards a TRIPS-compliant patent regime.

  • 231 The surveys indicated that 50% of pharmaceutical companies operating in Bangladesh strongly agreed (...)
  • 232 Interview with an official from a large local pharmaceutical company, in Dhaka, Bangladesh, 13 Marc (...)
  • 233 This view of large pharmaceutical companies was also supported by an official from a medium-sized l (...)
  • 234 Interview with the CEO of a local pharmaceutical company, in Dhaka, Bangladesh, 28 December 2009 (c (...)
  • 235 Interview with an official from BAPI, in Dhaka, Bangladesh, 23 January 2009.
  • 236 Interviews with IP academics and public health activists, in Dhaka, Bangladesh, 14 March 2012.
  • 237 Interview with a deputy registrar from the DPDT, in Dhaka, Bangladesh, 22 January 2009.
  • 238 Ibid.

118It is interesting to note here that, in contrast to some small pharmaceutical companies, the leading local pharmaceutical companies in Bangladesh, as well as the MNPCs operating there, all oppose the price control mechanism.231 One interviewee argued that “some companies are trying to seize the market with low price, low-quality products, which may become a real threat for public health”.232 This was echoed by another participant who claimed that price control might encourage both cheap drugs and, in a way, low-quality counterfeited pharmaceuticals.233 The CEO of one small pharmaceutical company argued that the “withdrawal of price control will become a threat for access to medicines and for their (small pharmaceutical companies) survival” as well. He added that “it is better to have price control to encourage local competition and ensure affordability of pharmaceuticals for the local people”.234 The BAPI made no comment on this issue, which it considered contentious from both legal and political perspectives, and admitted that there is a conflict of opinion among its members.235 Nonetheless, public health NGOs and IP academics in Bangladesh support a broadening of the role of price control and believe any attempt to withdraw price control will be a disaster.236 One official at the DPDT in Bangladesh argued that “reality shows that even the government is not able to control price effectively with the present ordinance. So the non-existence of price control would definitely lead towards a real disaster in terms of access to drugs”.237 He further added that “in the absence of it, the price of drugs would be sky- high, which would ultimately lead towards the real obstacle in order to access to drugs”.238

  • 239 The DCO was first passed in 1970 and then revised in 1979, 1987 and 1995. See for details, ‘Nationa (...)
  • 240 ‘Recommendations of the Task Force Constituted Under the Chairmanship of Proneb Sen to Explore Issu (...)
  • 241 Ibid., 1.1.

119India’s National Pharmaceutical Pricing Authority was established under the Drugs (Prices Control) Order, 1995239 and is entrusted to fix or revise the prices of controlled bulk drugs and formulations (bulk drugs are price controlled like the essential medicines list in Bangladesh), and to enforce prices and availability of medicines in India. It has also been empowered to recover amounts overcharged by manufacturers of controlled drugs for consumers, and to monitor the prices of decontrolled drugs to keep them at reasonable levels. However, drug control mechanisms in India are considered to be ineffective by the government-backed Dr Pronab Sen Taskforce.240 The taskforce argued that “no price regulatory mechanism can be effective unless there is a credible threat of price controls being imposed and enforced. However, it is also felt that often the present price control system is inappropriate, inadequate, cumbersome, and time consuming”.241

  • 242 Ibid., 1.2.
  • 243 Ibid., 1.5.

120The taskforce further recommended that “[p]rice controls should be imposed not on the basis of turnover, but on the ‘essentiality’ of the drug and on strategic considerations regarding the impact of price control on the therapeutic class. This must be a dynamic process”.242 It declared that “The ceiling prices of controlled drugs should normally not be based on cost of production, but on readily monitor-able market-based benchmarks”.243 Some other recommendations of the taskforce that may also be relevant for Bangladesh are:

  • A process of active promotion of generic drugs should be put in place, including mandatory debranding for selected drugs.

  • All public health facilities should be required to prescribe and dispense only generic drugs, except in cases where no generic alternative exists.

  • In the case of proprietary drugs, particularly anti-HIV/AIDS and cancer drugs, the government should actively pursue access programmes in collaboration with drug companies with differential pricing and alternative packaging, if necessary.

  • Public sector enterprises involved in the manufacture of drugs should be revived where possible and used as key strategic interventions for addressing both price and availability issues. Arrangements may need to be made to ensure their continuing viability.

    • 244 Taskforce to Explore Options, pp. 53–54.

    Fiscal incentives should be provided on a long-term assured basis to R&D activities in drugs.244

  • 245 Interview with a public health activist and policy analyst working with a public health-based inter (...)
  • 246 Interview with an IP lawyer working as an in-house legal counsel and regulatory affairs adviser at (...)
  • 247 A.K. Monaw-war Uddin Ahmad, ‘Competition, Regulation and the Role of the State: The Case of Banglad (...)

121One public health activist remarked that the Government of Bangladesh should also appoint a taskforce to review its drug control mechanism and that it would benefit immensely from the Indian taskforce suggestion to restructure the existing mechanism.245 However, another participant remarked that the Canadian approach is free from the problems identified by the Indian taskforce, and therefore an agency such as that in Canada—empowered as recommended by the Dr Pronob Sen Taskforce, particularly regarding the promotion of generic drugs and revival of public sector enterprises such as Essential Drugs Limited, a government pharmaceutical manufacturing facility in Bangladesh— may help Bangladesh to develop a unique mechanism to maintain access to medicines, to assess R&D investment in the pharmaceutical sector and to feed information back to the government on such matters as incentives like tax exemption and other policy measures.246 Some researchers, such as AK Monawar Uddin Ahmad, consider that the withdrawal of price controls for many pharmaceutical products do not lead to any rise in the price level, and that the MRP of some finished formulations actually decline due to competitive bulk drug pricing.247

  • 248 Fiona M. Scott Morton, ‘The Problems of Price Controls’, Regulation (2001), p. 50, http://object.ca (...)
  • 249 Ibid.
  • 250 Ibid., p. 53.
  • 251 See Patricia Danzon and Michael Furakawa, ‘Prices and Availability of Pharmaceuticals’, Health Affa (...)

122Price control also has some built-in limitations or problems. There is the possibility that it could disrupt the balance between supply and demand in the market. If prices are held below natural levels, resources such as talent and investor capital leave an industry to seek a better return elsewhere.248 There will be less discovery and innovation, and fewer new drugs will become available to consumers.249 Although supply and demand shift constantly according to the price of raw materials, production costs and local needs, the government price will change only after a lengthy political and bureaucratic process. Thus, the government price will effectively never be an equilibrium price: it will be either too high or too low.250 Price control could also affect the openness of competition and the availability of alternatives, which would tend to discourage rapid entry of generic medicines.251

  • 252 See generally Wendy J. Werner, ‘Micro-insurance in Bangladesh: Risk Protection for the Poor?’, Jour (...)
  • 253 For example, in the UK, “public health and insurance takes care of 83.4 percent of the spending on (...)
  • 254 Interview with patent lawyers and pharmaceutical researchers, in Dhaka, Bangladesh, 14 March 2012.
  • 255 Interview with public health activists, in Dhaka, Bangladesh, 16 March 2012. All activists supporte (...)

123In the context of Bangladesh, one important element that needs serious consideration is that the majority of drug costs are privately paid for in the absence of an effective health insurance system that provides access and availability to all.252 Price regulation in most countries involves the government purchasing medicines for delivery through the public health system or fixing reimbursement rates against insurance claims, but rarely fixing prices prevailing in the open market.253 Leading large and medium pharmaceutical companies are now more interested in exporting to other countries than in supplying the local market, due to low profits from price-controlled products.254 Similarly, MNPCs operating in Bangladesh are not interested in supplying products in the local market that are under price control and have low profit margins.255 In the absence of production by MNPCs and in the face of inadequate supply from leading local companies, small pharmaceutical companies with inadequate quality control are trying to seize an opportunity. Unless the price control mechanism works efficiently and in a timely manner with proper information about the market and relevant products, excessive price control in the long run will not give optimal results for public health in Bangladesh; rather, it could create a market for low- quality, cheaper products. Considering the limitations of price control, competition law may be an additional instrument for Bangladesh.

4.3.2 National Competition Law

  • 256 Sislu F. Musungu, Susan Villanueva and Roxana Blasetti, Utilizing TRIPS Flexibilities for Public He (...)
  • 257 TRIPS Agreement, art. 8.2; see ibid., art. 30; Thomas Cottier and Ingo Meitinger, ‘The TRIPS Agreem (...)
  • 258 ‘The Ability of Select Sub-Saharan Africa Countries to Utilize TRIPS Flexibilities and Competition (...)

124When implementing the TRIPS Agreement, members can prevent the abuse of IPRs and control anti-competitive practices either by integrating competition rules into the national IP law or by framing a separate competition law to prevent abusive monopoly practices or the abuse of a dominant position.256 Article 8.2 of the TRIPS Agreement permits WTO members to adopt “[a]ppropriate measures … to prevent the abuse of intellectual property rights … or … practices which unreasonably restrain trade or adversely affect the international transfer of technology”, while Article 40 of the TRIPS Agreement recognises the possible link between IP laws and competition policy.257 Therefore, the use of competition law and policy could provide developing countries with several advantages, including258 (i) countries will have flexibilities under the TRIPS Agreement to use a competition framework appropriate to their socioeconomic condition; (ii) countries will have the freedom to define what constitutes anti-competitive behaviour; (iii) competition law and policy are well suited for implementation by an independent competition authority vested with extensive investigative powers; and (iv) competition law and policy have already been used successfully by South Africa to reduce the price of essential medicines.

  • 259 The World Bank, ‘World Development Report: Building Institutions for Markets’ (2002), p. 147, https (...)

125A World Bank study emphasising the importance of developing and institutionalising appropriate competition policy for developing countries and LDCs stated that “Unless developing countries rapidly establish adequate competition frameworks and regulatory institutions that also address monopoly abuse of [intellectual property rights], it is possible that increasing [intellectual property right] protection could result in welfare losses from monopoly behavior”.259

  • 260 In Brazil, a competition law, Law No. 8,884/94, was replaced by an updated Competition Act, Law No. (...)
  • 261 In India, the Competition Act was enacted in 2002 to replace the Monopolies and Restrictive Trade P (...)
  • 262 See generally Carina Smit, The Rationale for Competition Policy: A South African Perspective (2005) (...)

126Therefore, the Government of Bangladesh should consider enacting a national competition law to prevent the abuse of monopoly pricing during the post-TRIPS patent regime. Brazil introduced a new competition law in December 2010,260 and India, in 2002.261 However, these countries have yet to effectively use competition law or policy for the pharmaceutical sector, whereas South Africa has already successfully implemented and tested its competition law in the pharmaceutical sector; therefore South African competition law appears to have a viable role to play in reducing the price of medicines262 and its model should be adapted to suit Bangladesh’s unique national circumstances.

  • 263 Medicines and Related Substances Control Amendment Act.

127In SouthAfrica, the Medicinesand Related Substances ControlAmendment Act, No. 90 of 1997263 created the grounds for using competition law to ensure access to medicines in cases of excessive pricing and abuse of a dominant position. This Act was introduced in response to the HIV/AIDS crisis the country had been facing and the lack of access to pharmaceuticals due to cost. Section 15C, considered controversial by the MNPCs, reads:

128Section 15C - Measures to ensure supply of more affordable medicines. The Minister may prescribe conditions for the supply of more affordable medicines in certain circumstances so as to protect the health of the public, and in particular may -

  1. notwithstanding anything to the contrary contained in the Patents Act, 1978 (Act 57 of 1978) determine that the rights with regard to any medicine under a patent granted in the Republic shall not extend to acts in respect of such medicine which has been put onto the market by the owner of the medicine, or with his or her consent;

    • 264 Ibid., § 15C.

    prescribe the conditions on which any medicine which is identical in composition, meets the same quality standard and is intended to have the same proprietary name as that of another medicine already registered in the Republic, but which is imported by a person other than the person who is the holder of the registration certificate of the medicine already registered and which originates from any site of manufacture of the original manufacturer as approved by the council in the prescribed manner, may be imported.264

  • 265 According to Court Case Between 39 Pharmaceutical Firms and The South African Government, CPTech, h (...)

129The above provision authorises the South African government to determine the extent to which a specific drug patent will apply. This provision was a direct challenge to the pharmaceutical industry.265 Such an enactment demonstrates that in becoming TRIPS-compliant, a nation may avail itself of some latitude within the flexibilities allowed under the TRIPS Agreement, particularly in pursuance of the imperative of public welfare.

  • 266 See Competition Commission Finds Pharmaceutical Firms.
  • 267 Ibid.

130The South African Competition Commission has already applied competition law successfully in the pharmaceutical sector to deal with restrictive practices and abuse of a dominant position. In Hazel Tau and Others v. GlaxoSmithKline and Boehringer Ingelheim, the prices set by these two companies were considered an obstacle to access to ARV medicines.266 The Competition Commission ruled that they had violated the Competition Act, 1998 by “1. Den[ying]a competitor access to an essential facility[,]2. Excessive pricing[,] and 3. Engag[ing] in an exclusionary act”, whereas the pharmaceutical companies claimed they were merely exercising the exclusive right granted through their patent as in many other countries.267 However, the commissioner stated:

  • 268 ‘Access to Patented Anti-HIV/AIDS Medicine’.

Our investigation revealed that each of the firms has refused to license their patents to generic manufacturers in return for a reasonable royalty. We believe that this is feasible and that consumers will benefit from cheaper generic versions of the drugs concerned. We further believe that granting licenses would provide for competition between firms and their generic competitors. We will request the Tribunal to make an order authorising any person to exploit the patents to market generic versions of the respondents’ patented medicines or fixed dose combinations that require these patents, in return for the payment of a reasonable royalty.268

  • 269 Ibid.

131Even though the two companies denounced the complaint as unfounded, they compromised by adopting voluntary licenses to produce a generic version of their patented pharmaceuticals. Since this case, there has been substantial progress in South Africa towards providing access to pharmaceuticals for anti-HIV and AIDS.269

  • 270 ‘Will Bangladesh’s New Competition Law Prove Effective?’.
  • 271 Quoted in Will Bangladesh’s New Competition Law Prove Effective?’.
  • 272 Karen Ellis Rohit Singh, Shaikh Eskander, and Iftekharul Huq, Assessing the Economic Impact of Comp (...)

132Bangladesh now has a competition law to prevent the abuse of monopoly pricing during the post-TRIPS patent regime. The Government of Bangladesh enacted the Competition Act, 2012 in June 2012.270 One study stated that “A draft bill for such a law was first proposed in 1996; however, it took sixteen years to finally come to fruition”.271 The progress of the bill has been delayed: “the political will to implement a competition law is limited, and there is some opposition from business groups”.272

  • 273 Ibid., p. 2.
  • 274 Ibid.

133Indeed, competition problems are potentially more serious in a country such as Bangladesh, which has “a weaker private sector, where one or a few dominant firms can take control” and abuse their dominant position.273 The media coverage suggests that “Bangladesh may suffer from significant competition problems, with substantial costs to consumers” and to the public health sector of Bangladesh, more particularly.274

  • 275 Shakhawat Hossain, ‘No Enforcement of Laws on Food Adulteration, Children, Fair Trade’, New Age (Dh (...)

134The Government of Bangladesh should utilise competition law so that its objective is the welfare of its population. Despite the enactment of the competition law in 2012, it is yet to be implemented, as the Ministry of Commerce in Bangladesh has not adopted the rules to enforce it.275

  • 276 ‘The Ability of Select Sub-Saharan Africa Countries’, p. 6.
  • 277 See Intellectual Property and Competition Law: Exploration of Some Issues.
  • 278 See ibid., pp. 13–19. In fact, these patents should never have been granted in the first place. Lac (...)
  • 279 See ibid., pp. 13–16.

135When considering weaknesses in the South African competition law, it is suggested that in any future Bangladeshi competition law, “to increase its effectiveness as a tool for reducing prices of essential medicines”, a competition commission should be empowered with the authority to issue compulsory licenses, recommend fixed royalty rates and expressly allow for the export of products produced under compulsory licenses to maintain sustainable investment.276 In addition, LDCs such as Bangladesh may also stipulate in national competition law that compulsory licensing could be granted in cases of anti-competitive behaviour, such as in the case of the patent holder’s unilateral refusal to grant a license (refusal to deal).277 Competition law could also be applied in the case of obtaining pharmaceutical patents in an unjustified and fraudulent manner.278 Issues of “poor quality” and “frivolous” patents and regulatory practices such as marketing approval and data exclusivity can also be controlled under competition law.279

  • 280 Interview with an IP academic from the University of Chittagong, in Chittagong, Bangladesh, 18 Janu (...)
  • 281 Interview with a public health activist, in Dhaka, Bangladesh, 23 January 2012.

136One interviewee argued that the use of competition law would be a viable tool for Bangladesh to prevent excessive pricing and to allow generic production of particular pharmaceutical products if there is any abuse of dominant position, as it would be extremely difficult for Bangladesh to allow a compulsory license under patent law due to political pressure from the developed countries.280 In contrast, another participant argued that even the use of competition law may also face political pressure, and that the competition authority should moreover have enough expertise and resources to guide its reasoning.281

137Another alternative government intervention mechanism is a prize system.

4.3.3 Patent Prize System

  • 282 See Joseph E. Stiglitz, ‘Scrooge and Intellectual Property Rights’, British Medical Journal 333 (20 (...)
  • 283 William W. Fisher and Talha Syed, ‘A Prize System as a Partial Solution to the Health Crisis in the (...)
  • 284 See generally Mayer Brezis, ‘Big Pharma and Health Care: Unsolvable Conflict of Interests Between P (...)

138The use of patent prizes as an alternative to patents, proposed by some scholars such as Joseph E. Stiglitz, could address the lack of incentive with respect to problems such as disease in developing countries, and it would provide immediately affordable pricing for products still under patent protection.282 In a prize system, “[i]nstead of authorizing drug developers to exclude competitors, the government would pay successful developers”, and therefore “[o]ther firms, including generic drug manufacturers, would be free to make and sell the drugs in question”.283 Some studies further suggest that many drug companies spend much of the money earned through patents on marketing and advertising, as opposed to research for new drugs.284

  • 285 Marlynn Wei, ‘Should Prizes Replace Patents? A Critique of the Medical Innovation Prize Act of 2005 (...)
  • 286 Michael Polanvyi, ‘Patent Reform’, Review of Economic Studies 11 (1944): 61, 65 (emphasis omitted).

139However, “[t]he controversy between a patent and prize systems [sic] reaches as far back as the nineteenth century”, when “commentators proposed ‘bonuses’ [be] granted to inventors by the government, professional associations financed by private industries, intergovernmental agencies, or an international association funded by private industries”.285 Michael Polanvyi trumpeted the idea of prizes as a means of patent reform in 1944, stating that “[i]n order that inventions may be used freely by all, we must relieve inventors of the necessity of earning their rewards commercially and must grant them instead the right to be rewarded from the public purse”.286 However, these suggestions did not garner much support.

  • 287 ‘Should Prizes Replace Patents?’, p. 29 (footnote omitted).
  • 288 Ibid.
  • 289 Ibid., p. 31.
  • 290 See generally Lee N. Davis, Should We Consider Alternative Incentives for Basic Research? Patents v (...)
  • 291 Michael Abramowicz, ‘Perfecting Patent Prizes’, Vanderbilt Law Review 56 (2003): 115, 121.

140The Royal Academy of Science in Paris had a prize system that “served as a model for scientific societies in other countries during the eighteenth and nineteenth centuries. The lack of a central authority or specific policy for prize distribution” made the prize system contentious and, some claimed, corrupt.287 “Academy members were at odds when trying to determine which fields should receive general prizes”, and “[s]uch disputes were only partly resolved by commissions represented by multiple disciplines. At the same time, prizes were becoming increasingly a matter solely of money, not honor”.288 The “ultimate question of whether the costs outweigh the benefits of a prize system over a patent system remains open” and is one that “can only be answered empirically”.289 Few studies have focused on the economic effects of prizes,290 and there is no consensus on how prize systems should be designed.291

  • 292 See generally Should We Consider Alternative Incentives for Basic Research?
  • 293 ‘Should Prizes Replace Patents?’, p. 26 (footnote omitted). Many authors have criticised the growin (...)
  • 294 ‘Should Prizes Replace Patents?’, p. 26. Only 10% of the world’s expenditure on R&D is spent on tar (...)
  • 295 ‘Should Prizes Replace Patents?’, pp. 26–27 (footnotes omitted).
  • 296 Ibid., p. 28 (footnotes omitted).
  • 297 Ibid., p. 34; see also ‘A Prize System as a Partial Solution’.
  • 298 ‘Proposal by Bolivia, Suriname and Bangladesh: Prizes as a Reward Mechanism for New Cancer Treatmen (...)
  • 299 ‘Proposal by Bolivia, Suriname and Bangladesh’, p. 2.
  • 300 Ibid.

141Nevertheless, a prize system may be designed to encourage local pharmaceutical companies and MNPCs to invest in R&D for the diseases most prevalent in Bangladesh. A prize system is justified on the grounds that granting patents stimulates a monopoly rather than the R&D necessary to deal with the particular problems of a country without resources such as Bangladesh, or of inventing something where there is no hope of a huge profit.292 Further, it is important to acknowledge the criticism that “the patent system and other exclusive rights contribute to high drug prices, global health inequities, limited access to potentially life-saving medicines and medical technologies, and the production of drugs that have little incremental therapeutic value”.293 In a system that rewards patent owners, pharmaceutical companies will target only affluent patients who can pay more or significantly higher prices that cover the cost of R&D and marketing; therefore, “pharmaceutical companies have little incentive to invest in R&D for low-return … neglected diseases, or other ‘non-profitable’ diseases”.294 The WHO estimates that approximately 10 million lives could have been saved with access to existing medicines and vaccines. The deadweight loss of monopoly pricing of drugs is anywhere between US$ 3 billion and $ 30 billion annually in the US drug market alone.295 In this context, a prize system has three underlying goals: (i) to provide incentives for R&D in new, significantly better medicines; (ii) to enhance access to medicines; and (iii) to focus more resources on non-profitable, neglected diseases.296 Considering potential benefits and limitations, Bangladesh could introduce a prize system while initially maintaining the patent system, rather than preventing patents altogether. The prize system should have as its principle criteria: (i) the number of patients benefited by the invention/innovation; (ii) “the incremental therapeutic benefits of the innovation; (iii) the degree to which the innovation addresses healthcare needs, including global infectious diseases, orphan illnesses, and neglected diseases affecting the poor in developing countries; and (iv) ‘[t]he improved efficiency of manufacturing processes for drugs’”.297 During WHA 60.30, “The governments of Bolivia, Suriname and Bangladesh present[ed] for discussion a proposal concerning the possible use of prizes as a new incentive mechanism for innovation in new cancer treatments and vaccines that would separate rewards to innovation from the price of the products”. This proposal is based on an earlier one presented by the governments of Barbados and Bolivia in April 2008 during the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property.298 As the proposal declares, “[a]ccess to new cancer treatments and vaccines in developing countries is limited, due to several factors including, but not limited to: poor medical infrastructure; inadequate screening; and the high costs of oncology equipment, services and medicines”.299 It also mentions that “[h]igh prices for new cancer drugs and vaccines either discourage use completely, or place enormous burdens on the healthcare budgets of developing countries. Treatments for several new cancer drugs exceed [US]$ 50,000 per completed course”.300

  • 301 Ibid.
  • 302 Ibid.
  • 303 Ibid. (emphasis omitted).

142However, this was not a proposal for a global prize fund; rather, it suggested that “national governments in developing countries introduce a new system of rewarding the development of new medicines and vaccines for cancer”.301 Specifically, it proposed “that developing countries de-monopolize the entire sector of medicines and vaccines for cancer, and permit free entry by generic suppliers”.302 The proposal further stated that “[i]n return for ending the monopoly, developing country governments would offer to provide a domestic system of rewards for developers of new medicines and vaccines for cancer that is based on a fixed percentage of the national budget for cancer treatments”.303

  • 304 Ibid., p. 3; see also TRIPS Agreement, arts. 30, 31, 44.
  • 305 CPTech, Proposal for Treaty on Medical Research and Development’ (February 2005), http://www.cptec (...)
  • 306 Ibid.

143It was argued that such a proposal was consistent with the TRIPS Agreement as developing countries “can eliminate the exclusive rights to use patented inventions, in cases where patent owners receive remuneration or compensation”.304 However, there has been no outcome from this proposal despite the fact that “[o]n February 24, 2005, some 162 leading medical researchers, NGOs, parliamentarians, government officials, and other stakeholders submitted a letter to the [WHO] asking that it evaluate a proposal for a new global treaty to support medical R&D”.305 The letter proposed “to deal with higher drug prices for consumers in developed and developing countries by introducing a Medical R&D Treaty Framework that could ultimately replace existing or planned trade agreements that focus on patents or drug prices”.306

144According to Andrew Farlow:

  • 307 Andrew Farlow, ‘A Global Medical Research and Development Treaty: An Answer to Global Health Needs? (...)

In late 2005 Kenya formally submitted a resolution to the WHO’s Executive Board (WHO EB) asking for the creation of a working group of member states to consider the [Medical R&D Treaty (MRDT)]. In January 2006 Brazil co-sponsored the resolution. Subsequently, the WHO EB approved a heavily bracketed version of a draft resolution. That draft was debated at the World Health Assembly (WHA) in late May 2006.307

  • 308 Ryan Abbot, ‘Potential Elements of the WHO Global R&D Treaty: Tailoring Solutions for Disparate Con (...)
  • 309 Ibid.
  • 310 WHO, ‘Research and Development to Meet Health Needs in Developing Countries: Strengthening Global F (...)

145The MRDT would require all countries—rich and poor—to pledge to spend a fixed percentage of their GDP on medical R&D.308 The WHO Consultative Expert Working Group (CEWG) Report also proposed the creation of a new binding agreement to provide billions of dollars annually for R&D to address the special healthcare needs of poor persons living in developing countries, and to introduce new approaches to funding R&D that included open innovation models, the delinking of R&D costs from product prices, and technology transfer and capacity building in developing countries.309 However, the CEWG Report also stated that “[w]e see a convention not as a replacement for the existing intellectual property rights system, but as a supplementary instrument where the current system does not function”.310

  • 311 WHO Tackles Intellectual Property, R&D Treaty’, Bridges Weekly Trade News Digest (27 May 2009): 1, (...)
  • 312 See James Love, ‘WHO negotiators propose putting off R&D treaty discussions until 2016’, Knowledge (...)

146On the other hand, there was contention regarding suitability of the WHO as a forum to negotiate a relevant treaty. That is why it was stated that “although the sponsors believe that a treaty on MRDT would considerably ‘transform the landscape of biomedical innovation to incorporate needs-driven health research and development’, several developed country members, primarily the US and the EU, said that the WHO was not an appropriate forum for discussing the treaty”.311 Finally, the WHO negotiations on MRDT ended without any concrete action; instead, the WHO deferred the issues until 2016 by deciding to convene another open-ended meeting of member states prior to the 69th WHA in May 2016 in order to assess progress and continue discussions on the remaining issues in relation to monitoring, coordination and financing for health R&D.312 Public health groups like Knowledge Ecology International (KEI) criticised the outcome:

  • 313 Ibid.

A treaty on R&D financing would have not have cost the United States any money, while creating obligations on other countries to pay more for global health R&D projects. The only reason for blocking this initiative was to protect the existing drug development business model. The existing model benefits big pharma the most, and exploits consumers and marginalizes the poor.313

  • 314 Based on interview responses from pharmaceutical academics and researchers.

147On the basis that there is no international scheme, Bangladesh could try a country-specific prize fund picking on the most preventable diseases in Bangladesh. During the author’s surveys of pharmaceutical companies in Bangladesh, no one showed any interest in the prize system. However, pharmaceutical researchers and public health NGOs who were interviewed considered it a viable option.314

148Limiting data protection is another policy position in need of consideration by the Government of Bangladesh.

4.3.4 Limit Data Protection

  • 315 Carlos M. Correa, Protecting Test Data for Pharmaceutical and Agrochemical Products under Free Trad (...)
  • 316 “Data exclusivity was first introduced in 1987 in a number of European countries to compensate for (...)

149To gain marketing approval for any newly developed pharmaceuticals, companies are required to submit test and clinical data relating to safety and efficacy to national health authorities.315 The data exclusivity provisions “refer to a practice whereby, for a fixed period of time, national drug regulatory authorities prevent and block the registration files of an originator to be used to register a therapeutically equivalent generic version of that medicine without obtaining the consent of the patent holder unless the generic manufacturer actually conducts the clinical trials again”.316

150Supporters of data exclusivity provisions consider it important to compensate for inordinate delays in granting patents and also to recover investment and research costs for innovators. On the other hand, generic companies believe:

  • 317 Data Exclusivity, European Generic Medicines Association, http://www.cptech.org/ ip/health/dataexcl

Data exclusivity has nothing to do with protecting research data. Long after the data exclusivity period has expired, the originator documentation remains protected by copyright laws and other legal provisions. Data exclusivity merely extends the originator company’s market monopoly over a product by not allowing the authorities to process an application for marketing authorisation.317

  • 318 ‘Integrating Intellectual Property Rights’, p. 62.

151Therefore, “[d]ata exclusivity can be a barrier to generic entry irrespective of whether the drug was patented, or if the patent period has expired”.318

  • 319 Animesh Sharma, ‘Data Exclusivity with Regard to Clinical Data’, The Indian Journal of Law and Tech (...)
  • 320 Ibid., p. 84.

152In India, when generic companies apply for approval of a pharmaceutical, they are not required to conduct their own studies and submit independent data.319 Rather, companies can rely on the safety and efficacy data submitted by the innovator company to obtain marketing approval for their products.320

  • 321 Article 39.3 of the TRIPS Agreement states: Members, when requiring, as a condition of approving th (...)
  • 322 Sudip Chaudhuri, ‘TRIPS and Changes in Pharmaceutical Patent Regime in India’ (Indian Institute of (...)
  • 323 Ibid.
  • 324 Ibid.
  • 325 Ibid.; see TRIPS Agreement, art. 39.3.
  • 326 Sudip Chaudhuri, p. 19.
  • 327 Ibid.
  • 328 Ibid., 20.

153Article 39.3321 of the TRIPS Agreement is being interpreted by some MNCs and some developed countries, particularly the US, “to mean that WTO member countries are required to grant data exclusivity for a specified period of time”.322 However, after tracing the history and text of Article 39, scholars “have concluded that the protection need not be in the form of data exclusivity”.323 If data exclusivity “were the intention then the terms ‘exclusive rights’ would have been used as in Article 70.9” of the TRIPS Agreement.324 Article 39.3 requires countries to “protect data against ‘unfair commercial use’”325 and countries “have the discretion to [protect data] not through data exclusivity but by proscribing situations where a competitor obtains the results of testing data through fraud, breach of confidence or other ‘dishonest’ practices and derive a commercial advantage”.326 Thus, “[p]rotection is not necessary if regulatory authorities do not require the submission of such data for marketing approval or if the data are already public”.327Protection should only be required for new chemical entities so that each country can have considerable freedom “in defining what is ‘new’, and may exclude the different formulations based on the same chemicals”.328

154Thus, the TRIPS Agreement requires “data protection” but does not require data exclusivity, as there is a clear distinction between these two concepts. Data exclusivity involves a monopoly right over test data for a certain period of time, whereas data protection only requires authorities to keep the data confidential. A WHO study quite clearly states that:

  • 329 WHO, Intellectual Property Rights and Access to Medicines: A South-East Asia Perspective on Global (...)

Given the negative impact on public health and access to medicines of providing for data exclusivity, it is important that developing countries try to avoid it. If unable to avoid data exclusivity, countries should limit the duration of data exclusivity as well as its scope (e.g., only for new chemical entities, and only for undisclosed data). Countries should also consider creating exemption mechanisms by which they can exempt products from data exclusivity provisions if necessary.329

155Moreover, the CIPIH Report reaffirms this under Recommendation 4.20, which states:

  • 330 CIPIH Report, p. 126.

Developing countries need to decide in the light of their own circumstances, what provisions, consistent with the TRIPS agreement, would benefit public health, weighing the positive effects against the negative effects. A public health justification should be required for data protection rules going beyond what is required by the TRIPS agreement. There is unlikely to be such a justification in markets with a limited ability to pay and little innovative capacity. Thus, developing countries should not impose restrictions for the use of or reliance on such data in ways that would exclude fair competition or impede the use of flexibilities built into TRIPS.330

  • 331 In the surveys, representatives from all the local pharmaceutical companies, regardless of their si (...)
  • 332 Ibid.
  • 333 Interview with an academic from the University of Dhaka, in Dhaka, Bangladesh, 13 March 2009 (discu (...)
  • 334 From a survey response by one MNPC, Dhaka, Bangladesh, 22 January 2009.

156During the surveys for this study, all but one participant argued that Bangladesh should not give any test data protection.331 They also believed that it would be beneficial to follow the Indian approach and allow generic competition.332 One participant argued that granting test data protection over clinical and pre-clinical trial data could restrict entry of generic medicines, given that local pharmaceutical companies in Bangladesh lack the financial and technical resources to conduct original clinical trials.333 However, one MNPC remarked in the survey that “test data protection may encourage foreign direct investment and technology transfer in Bangladesh”.334

157As an LDC, Bangladesh is still enjoying the Doha waiver for pharmaceutical patents; therefore, it currently has no test data protection system. Bangladesh should maintain that position to help local generic producers, while working towards creating a patent pool in cooperation with other countries and private organisations.

4.3.5 Patent Pool on Country-specific Diseases

  • 335 See Steven C. Carlson, ‘Note, Patent Pools and the Antitrust Dilemma’, Yale Journal on Regulation 1 (...)
  • 336 See Robert P. Merges, ‘Institutions for Intellectual Property Exchange: The Case of Patent Pools’, (...)
  • 337 Manisha Singh Nair, Rationality of a Patent Pool (12 December 2009), http://ipfrontline.com/2009/04 (...)
  • 338 Ibid.

158A patent pool is an agreement between two or more patent owners to license one or more of their patents to one another, or to third parties, whether they are transferred directly by the patentee to license, or through any medium—such as a joint venture—set up specifically to administer the patent pool.335 Therefore, a patent pool is a mechanism through which various patents held by different entities such as companies, universities and research institutions are made available to others for production or further development.336 The patent holders receive royalties for the use of the patent not from the user directly, but from the pool management.337 Patent pools are increasingly seen as a useful tool for tackling barriers to access to medicines in developing countries through the sharing of knowledge and technologies.338

  • 339 Ibid.
  • 340 WHO, KEI, Intergovernmental Working Group Submission on Collective Management of Intellectual Prope (...)
  • 341 Ibid.
  • 342 Ibid.

159The rationale for creating a patent pool is that it helps lower the price of pharmaceuticals and enhances innovation by considering particular local health needs.339 Further, “[a] patent pool that licenses patents in several countries can ensure that generic manufacturers operate in efficient economies of scale” and can provide enhanced capacity to manage legal issues in the face of a multitude of patents, potential claims of infringement, variance of national laws, complexity of international treaties and national patent laws, and “complicated rules for the export of medical technologies under compulsory licenses present barriers for the expanded use of generic medicines”.340 Patent pool managers “have the expertise and capacity to manage issues that arise on behalf of governments, donors, public health agencies, patent owners and generic manufacturers”.341 It is also worth noting that collective management of the patent pool “will help [establish] global ‘best practice’ norms for licensing on such issues as quality control, remuneration, open competition, etc”.342

  • 343 David de Ferranti, ‘Can Patent Pools Get More AIDS Drugs to Patients?’, Huffington Post (9 April 20 (...)
  • 344 Ibid.

160The WHA discussed patent pools back in 2008 and later in the CEWG Report, and considered it a feasible mechanism to accelerate the availability of newer, low-cost medicines in developing countries.343 However, the possibility of creating a Medicines Patent Pool (MPP) was first proposed to UNITAID in 2006 by KEI and Médecins Sans Frontières following a proposal by KEI at the International AIDS Conference in 2002.344 UNITAID played an instrumental role in the creation of the MPP and decided to explore the possibility of establishing a MPP in July 2008. Finally, UNITAID decided in December 2009 to create and fund a patent pool focusing on increasing access to HIV medicines in developing countries; this became a reality in July 2010. It has been endorsed by the WHO, the UN High Level Meeting on AIDS, and the Group of 8 as a promising approach to improving access to HIV medicines.

  • 345 For details about the working procedure of the Medicines Patent Pool (MPP), see About the MPP, Medi (...)

161The MPP negotiates with patent holders to license to the MPP.345 This means that the patent holder allows other producers to manufacture and sell low-cost, high-quality versions of patented medicines in developing countries, or to develop adapted formulations under certain terms and conditions. The MPP seeks licenses that push the status quo in the direction of greater access to medicines—covering more countries, and under public health-oriented terms and conditions—with the ultimate aim of ensuring all people living with HIV in developing countries can access the treatment they need at affordable prices.

  • 346 Ibid.
  • 347 Ibid.

162Once the license is signed with the original patent holder, the MPP proceeds to make sub-licenses with low-cost generic manufacturers and other entities. The manufacturer is then free to develop, produce and sell the medicine in the agreed countries under strict quality assurance. It is stated that “[t]he MPP will particularly ease the development and production of fixed dose combination drugs (FDCs) that have proven to simplify treatment for people living with HIV and facilitate treatment scale-up in developing countries, and medicines suited for the specific needs of children”.346 In this way, more people can be treated for the same cost, which is crucial in a climate of increasing needs and funding challenges: “Patent holders can get a small royalty on the sales of the medicines, and people living with HIV get access to affordable, adapted treatment they need at prices they can afford”.347 Figure 4.1 depicts the working procedure of the MPP. 

Figure 4.1: Working procedure of the Medicines Patent Pool348

Figure 4.1: Working procedure of the Medicines Patent Pool348

163In analysing the importance of the MPP, it was remarked in the

164Huffington Post:

  • 349 ‘Can Patent Pools Get More AIDS Drugs to Patients?’.

As of today, the history of the MPP is still being written. It will be important to see over the coming year whether this patent pool will become large enough to effectively accelerate the production of low-cost generic versions of new AIDS drugs and the creation of the fixed dose combinations. Millions of patients in countries around the world will be affected by what happens.349

  • 350 Article 66.2 of the TRIPS Agreement provides that “Developed country Members shall provide incentiv (...)
  • 351 “Article 67 of the TRIPS Agreement sets out developed countries’ commitments on technical cooperati (...)
  • 352 During interviews, this was supported by IP academics, pharmaceutical researchers and public health (...)

165Bangladesh could consider a patent pool structure for prevalent diseases in consultation with other countries needing such pharmaceuticals. This could be accomplished by using Articles 66.2350 and 67351 of the TRIPS Agreement to seek technical and financial cooperation from developed countries for developing a patent pool for specific diseases. During the surveys, none of the pharmaceutical companies expressed any interest in a patent pool. However, some interviewees argued that this option may help Bangladesh gain technological and financial assistance from developed countries on country-specific diseases.352

166Further, Bangladesh should avoid entering any agreements that limit flexibilities allowed under the TRIPS Agreement or that could impose any TRIPS-plus obligations.

4.3.6 Avoiding Bilateral Investment Treaties or Free Trade Agreements that Erode TRIPS Flexibilities

  • 353 ‘Good Practice Guide’, p. 49, http://content.undp.org/go/cms-service/stream/asset/?asset_id=3259443

167The ability of LDCs like Bangladesh to utilise the flexibilities of the TRIPS Agreement “is being slowly eroded away through various bilateral and regional negotiations with developed countries”.353

  • 354 Peter Drahos, ‘BITS and BIPS: Bilateralism in Intellectual Property’, Journal of World Intellectual (...)
  • 355 ‘Good Practice Guide’, p. 49; Drahos, p. 802.
  • 356 ‘Global Communication on HIV and the Law’, p. 25; see also ‘Good Practice Guide’ and ‘TRIPS-plus Fr (...)
  • 357 The Trans-Pacific Partnership Agreement (TPP) was based on an agreement originally concluded in 200 (...)
  • 358 The Anti-Counterfeiting Trade Agreement (ACTA) is a multinational treaty that aims to establish an (...)

168High-income and industrialised countries—particularly the US and the EU—put pressure on developing countries and LDCs to introduce TRIPS-plus provisions: for example, commitments beyond those specified by TRIPS and providing more extensive protection than TRIPS.354 TRIPS-plus provisions are “introduced through bilateral agreements, such as free trade agreements (FTAs) and investment treaties”.355 Between 2001 and 2010, “72 FTAs with intellectual property clauses have been announced to the WTO. Of specific concern are the FTAs between developed countries and markets, most notably the US and the EU with low and middle income countries”, because extensive patent provision in the FTAs restricts utilisation of TRIPS flexibilities and hence presents barriers to the access of essential pharmaceuticals.356 More recently, serious concerns have been raised regarding the Trans- Pacific Partnership Agreement (TPP)357 and the Anti-Counterfeiting Trade Agreement (ACTA),358 due to the inclusion of TRIPS-plus patent provisions that may have serious effects on public health. LDCs like Bangladesh should be aware of the various TRIPS-plus provisions that can have a negative effect on the use of TRIPS Agreement flexibilities and subsequently on access to affordable medicines. Some of the most common TRIPS-plus provisions related to public health and access to medicines are:

    • 359 LDCs may need to adopt TRIPS-compliant national law, including pharmaceutical patents, despite the (...)

    waiving the LDC exception as allowed under the TRIPS Agreement359

  • defining “innovation” for the purposes of determining patent protection to include minor “me-too” molecular variations

  • restricting patent oppositions

  • extending patent terms beyond 20 years for delayed marketing approval

  • limiting parallel imports of patented drugs

  • restricting grounds for compulsory licensing

  • imposing “data exclusivity” rules

    • 360 See Gaelle P. Krikorian and Dorota M. Szymkowiak, ‘Intellectual Property Rights in the Making: The (...)

    linking patent systems to drug regulatory systems.360

  • 361 ‘Trading Away Health: How the US’s Intellectual Property Demands for the Trans-Pacific Partnership (...)

169These TRIPS-plus provisions, if adopted by developing countries and LDCs, will outweigh the benefits of the TRIPS flexibilities for the country concerned and will have severe consequences for access to medicines.361 The pressure to adopt more extensive protection than required by the TRIPS Agreement has also led to a floor vs. ceiling debate regarding an eventual international IP regime.

  • 362 See Annette Kur and Henning Grosse Ruse-Khan, ‘Enough is Enough: The Notion of Binding Ceilings in (...)

170Annette Kur and Henning Grosse Ruse-Khan argue that advancing the concept of a ceiling for the TRIPS Agreement would protect flexibilities from encroachment by “IP maximalists”:362

  • 363 Ibid., p. 1.

[T]he concept of maximum rights or “ceiling rules” which provide for a binding maximum amount of IP protection that WTO Members can offer in their national laws … [to] maintain a balanced approach towards IP protection, and to protect member states’ autonomy in preserving public policy goals vis-à-vis pressure exerted against them in bilateral trade negotiations.363

  • 364 Ibid.

171According to them, TRIPS Article 1:1 provides that “[M]ore extensive protection may only be granted ‘provided that such protection does not contravene the provisions of this Agreement’. In spite of that, the general perception in international IP regulation so far has been that above the prescribed minimum standards there is no ceiling or limit other than the sky”.364

  • 365 See generally ‘Universal Minimum Standards’, p. 345.
  • 366 Ibid., p. 351.
  • 367 See Global Intellectual Property Center, ‘TRIPS: Floor Versus Ceiling?’ (26 January 2010), p. 4, ht (...)

172On the other hand, J.H. Reichman states that with the mandates, the TRIPS Agreement has established a floor for global IP norms.365 Reichman contends that “states must accord to the nationals of other member states those international minimum standards of intellectual property protection that are comprised within ‘the treatment provided for in this Agreement’”.366 The US Government and its industry lobbyists argue that the TRIPS Agreement should not only be preserved as the “floor” for global standards, but that more attempts need to be made to strengthen the TRIPS Agreement and other agreements to upgrade legal systems and enforcement mechanisms in the field of IP.367

173To date, there has been no debate at the WTO or other international bodies regarding the introduction of a ceiling or maximum protection restriction, nor any proposal in support of it from the developing countries or the LDCs. In the absence of any maximum limit, a country could frame its IP law based on its comparative advantage in a specific (R&D-based) area of innovation or imitation. Additionally, considering the importance of other societal values and public good beyond those of commercial interest, as well as the country’s stage of development, LDCs and developing countries may need distinct types of ceilings. Any binding international regime on the ceiling, at least if placed within the WTO, could potentially open the door to further complex legal disputes under the WTO dispute settlement body and could further jeopardise the ongoing process of developing policy space for access to medicines and other developmental goals in the LDCs.

  • 368 Since 2003, Bangladesh has been negotiating a Trade and Investment Framework Agreement (TIFA) with (...)

174Therefore, LDCs such as Bangladesh need not adopt any ceiling on IPRs at the national level, but instead can keep the space open to strengthen IPRs in future, if local industry matures and engages in innovation. Bangladesh should try to avoid any TRIPS-plus obligations in free trade and investment agreements with the US, the EU or any other developed countries, and it may need to be aware of and try to mitigate TRIPS-plus obligations in various bilateral and regional free trade or investment agreements.368 Although avoiding TRIPS-plus obligations will allow LDCs like Bangladesh the freedom to utilise TRIPS flexibilities, LDCs could also lobby for further extension of the TRIPS waiver in general and of pharmaceutical patent waivers in particular.

4.3.7 Utilisation of the Transitional Period for Pharmaceutical Patents

  • 369 Sheikh Hasina, Prime Ministerof Bangladesh, Speech to the 64th WHA (17 May 2011), http://www.who.in (...)
  • 370 Ibid.

175In light of the vulnerable position of LDCs due to their socioeconomic conditions and weak public health infrastructures, the introduction of pharmaceutical patents will further marginalise LDCs in terms of coping with the prevailing situation. Bangladesh, in cooperation with other LDCs, lobbied for a further extension of the transitional period for pharmaceutical patents beyond 2016 to give the LDCs more time to develop their infrastructure and local pharmaceutical industry for dealing with public health problems in a post-TRIPS setting. The prime minster of Bangladesh has argued that it is necessary for LDCs like Bangladesh to receive another 15-year extension because of their weak infrastructure and vulnerable health conditions, and the nascent stage of their pharmaceutical industry.369 During her speech to the 64th WHA (17 May 2011), Bangladeshi Prime Minister Sheikh Hasina reiterated that the flexibilities accorded within the existing IP regime, in particular the patent waiver for LDCs for pharmaceuticals, must be extended further.370

  • 371 “Special and Differential Treatment” (S&D) may be sought to extend the transition period until grad (...)
  • 372 S&D is a set of GATT provisions (GATT 1947, Article XVIII) that exempts developing countries from t (...)

176In this respect, Bangladesh argued that the socioeconomic situation, low level of development, and health and technical infrastructure at the time of the original transitional period are still prevalent in LDCs; therefore, graduation to a pharmaceutical patent regime will have a huge negative effect on Bangladesh.371 Unless there is considerable progress in the social and economic development of the LDCs, growth of health infrastructure, and an increase in the accessibility and availability of medicines, Bangladesh should argue for the continuation of the waiver for pharmaceutical patents under the principle of special and differential treatment for the derogation from commitment.372

  • 373 WTO Council for TRIPS, ‘Elements Paper on the Extension of the Transition Period under Article 66.1 (...)

177On 11 November 2011, on behalf of the LDC Group, the delegation of Bangladesh to the WTO submitted to the TRIPS Council an elements Paper on the extension of the TRIPS transition period for LDCs. The Paper mentioned that LDCs are facing serious economic, financial and administrative constraints on their efforts to bring their domestic legal systems into conformity with the TRIPS Agreement.373

  • 374 This position was supported by all the large, medium and small local pharmaceutical companies in Ba (...)
  • 375 During the surveys, this position was supported by all the MNPCs operating in Bangladesh.
  • 376 Interview with an expert at the DDA in Bangladesh, in Dhaka, Bangladesh, 12 January 2012.
  • 377 Interview with a deputy registrar from the DPDT, in Dhaka, Bangladesh, 22 January 2012.

178Most of the survey participants in Bangladesh argued that the Government of Bangladesh, along with those of other LDCs, should lobby for a further extension for pharmaceutical patents until graduation from the LDC category.374 However, the MNPCs that participated in the surveys argued that a further extension of the waiver for pharmaceutical patents would not benefit Bangladesh; rather, it would hamper technological development and further investment in the sector.375 In contrast, one interviewee argued that the local pharmaceutical sector in Bangladesh is yet to achieve sufficient R&D to compete with the MNPCs; therefore, a further extension will help them to engage in R&D and prepare themselves for the transition to a pharmaceutical patent regime.376 One expert from the DPDT commented that, in light of the technical and infrastructural limitations of the DPDT, it would be better to have a transition period until graduation from LDC status for the introduction of pharmaceutical patents.377 The Government of Bangladesh, in cooperation with other LDCs, strongly lobbied for further extension of pharmaceutical patents, considering their present stages of technological capability and infrastructural development.

179However, a simple extension of the transitional period without any concrete steps to promote the advancement of the pharmaceutical industry would be useless. Therefore, LDCs such as Bangladesh should use the transitional period as part of a national strategy aimed at encouraging pharmaceutical production and investment in R&D-based industry for progression towards innovation and TRIPS compliance. One such strategy is to introduce a process patent and utility model law to encourage weak or low-level national innovation and, consequently, promote technological learning and progress on basic research.

4.3.8 Provision for Process Patent during the Transitional Period and Adoption of a Utility Model Law

  • 378 See WHO (19 WHO Drug Info), p. 238.

180Before adoption of the TRIPS Agreement, many countries provided only process—not product—patents because process patents would still allow for the manufacture of patented products using a different process or method. This has enabled manufacturers in certain countries, including India, to make and become global suppliers of generic versions of patented drugs.378

  • 379 See Sudip Chaudhuri, ‘The WTO and India’s Pharmaceutical Industry’ (2005); ‘TRIPS and Changes in Ph (...)

181Despite having a long tradition of drug manufacturing, India’s patent law (Patent Act, 1911) until 1970, placed constraints on its ability to use the full potential of its local industry. By introducing only process patents along with other supporting industrial policies, India was able to dislodge the MNPCs from their position of dominance and become a major pharmaceutical-producing nation. As Chaudhuri states, “India emerged as a global pharmaceutical supplier due to: the development of process technology by indigenous enterprises; the externalities associated with the setting up of two major public enterprises; the close association between manufacturers and government laboratories; and the patent and industrial policies since the 1970s supporting process patent”.379

182Bangladesh still adheres to the Patent Act, 1911 (as did India, until 1970), but the country should follow in India’s footsteps by introducing process patents and encouraging the local pharmaceutical industry to invest in R&D. Local pharmaceutical industry could also work in cooperation with local research institutions and universities.

183In addition to process patents, the Government of Bangladesh could introduce a utility model law. This could play a very important role in promoting innovative activity not only in the pharmaceutical sector but also in emerging local industries in the fields of information technology, textile manufacturing, telecommunications and biotechnology. In Bangladesh, there are many small- and medium-sized enterprises (SMEs), including pharmaceutical companies with inventive ideas; however, they often do not file patent applications due to the high cost of acquiring a patent, bureaucratic hurdles, long delays in acquiring a patent and a lack of confidence in their ability to satisfy high patentability requirements.

  • 380 Based on the survey data from local large, medium and small pharmaceutical companies in Bangladesh. (...)
  • 381 See Uma Suthersanen, ‘Utility Models and Innovation in Developing Countries’ (February 2006), pp. 5 (...)

184However, the surveys show that most local pharmaceutical companies believe a simple system that could grant protection quickly would help them to grow and further innovate.380 Bureaucratic delays and expensive filings could be avoided if a simple system were in place. Such a system could, given a broad scope, help in overcoming the lack of incentives for inventions excluded from patent protection.381 It is important to require relative, rather than absolute, novelty for a utility model and also decrease the amount of time it takes to review and grant patents, which currently stands at up to five years. Adopting relative novelty will ensure that innovators achieve utility model protection quickly by way of simple examination, even if the patent application contains only weak innovation—such as if there is at least one difference between the invention and the prior art.

185A utility model law, along with the introduction of process patents, would play an important role in filling the gap in law for promoting local—albeit weak—inventions, while also encouraging further research and innovation. However, it would be better for Bangladesh to introduce process patents under the existing patent law and to adopt a separate law on utility models to encourage local innovation, as local industries are yet to attain adequate technical capacity and financial resources for basic research and, hence, for product patents. In addition to the process patent and utility model, the Government of Bangladesh could also consider introducing special investment protection measures for the pharmaceutical industry to promote further investment, joint ventures, technology transfer and basic research.

4.3.9 Special Investment Protection Regime, Open Drug Innovation Model and Promotion of Social Business Model in the Pharmaceutical Sector

  • 382 Suerie Moon J. Bermudez, E. ‘t Hoen, ‘Innovation and Access to Medicines for Neglected Populations: (...)
  • 383 See Shamnad Basheer, ‘The Invention of an Investment Incentive for Pharmaceutical Innovation’, Jour (...)
  • 384 Ibid., pp. 46–48.
  • 385 Ibid.

186LDCs such as Bangladesh need to introduce some alternative ways of promoting innovation for country-specific diseases and attracting investment during the TRIPS-waiver periods, as in the absence of patent protection there might be little desire for innovation or investment in the pharmaceutical sector. It was stated in a study that “there is a lack of new medicines for the ‘neglected diseases’—those that primarily affect populations with little purchasing power, and therefore offer an insufficient incentive for industry to invest in R&D”.382 Therefore, developing countries and LDCs should devise a special investment regime to encourage investment in research related to country-specific neglected diseases and urge local research institutions to join an open drug innovation model in the absence of huge financial resources for basic research. Basheer proposed a comprehensive investment protection regime based on the compensatory liability model, which would grant comprehensive market exclusivity for new drugs against free riders until such time as the investment in the discovery and development of that drug is recouped. He considered that it might be more preferable to a patent regime.383 He further recommended a reimbursement model in which the costs of drug discovery and development could be reimbursed through public funding and prizes.384 Unlike patents and data exclusivity for uniform periods of protection, the proposed regime would reward a rate of return on investment dependent, inter alia, on the health value of the drug.385

  • 386 Ibid., p. 309.
  • 387 Carlos Correa, ‘TRIPS and R&D Incentives in the Pharmaceutical Sector’ (Communication on Macroecono (...)

187However, Basheer considers that his proposed investment protection regime is better suited to fostering cures for developed country diseases prevalent in the US and the EU.386 Considering the huge cost of basic research and drug development, and the minimal financial resources of consumers in LDCs like Bangladesh, this kind of investment regime could be of limited help to generate investment in LDC-specific diseases. Most developing countries and LDCs such as Bangladesh have clearly different pharmaceutical demands to those of developed countries: “The diseases of the poor attract very little R&D efforts by the large pharmaceutical industry, since they are not promising income generators. R&D is driven by market considerations. R&D targeting diseases found in developing countries is marginal”.387

  • 388 See generally Globalization and Access to Drugs.

188Despite the lack of patent protection for pharmaceuticals in Bangladesh until the patent waiver for LDCs expires, the Government of Bangladesh could introduce a special investment protection regime to encourage investment and technology transfer in the pharmaceutical sector by providing “exclusive marketing rights” for the same duration as a patent. The government could also provide tax incentives for a certain period of time. In this regard, Bangladesh could set two preconditions for getting special investment protection: (i) investment and/or technology transfer in an area of neglected diseases or diseases prevalent in Bangladesh; and (ii) any drugs produced under the investment or by way of technology transfer—if intended for offer in the local market—must satisfy requirements for licensing and market authorisation by the DGDA in Bangladesh.388

  • 389 Open source is “a way of sharing data, expertise, and resources to increase collaboration, transpar (...)
  • 390 See Stephen M. Maurer A. Rai, and A. Sali, ‘Finding Cures for Tropical Diseases: Is Open Source an (...)
  • 391 “The Tropical Diseases Initiative (TDI) modelled itself explicitly on open source approaches as ear (...)
  • 392 “TDR Targets is a WHO/TDR database that facilitates prioritization of potential drug targets across (...)
  • 393 Collaborative Drug Discovery is a California-based company that has “created a platform for selecti (...)
  • 394 The Lilly TB Drug Discovery Initiative is a not-for-profit public-private partnership headquartered (...)

189The Government of Bangladesh could also encourage local research institutions and pharmaceutical companies to engage in the development of a new open source drug innovation model and to participate in existing open source drug discovery models.389 These models are based on the idea that the sharing of medical information and international collaboration among scientists will advance medical research and, ultimately, help patients all over the world who are suffering from neglected diseases.390 As an example, Bangladesh could follow the Indian Open Source Drug Discovery (OSDD) project to encourage research on the diseases prevalent in Bangladesh. The Indian OSDD project works with a collaborative online platform where contributors can collectively discover new therapies for neglected diseases, beginning with TB research. It began in 2008 with US$ 12 million in funding provided by the Indian government, which also gave a commitment to invest US$ 35 million total in the project. In a similar vein, the Government of Bangladesh could provide some initial funding and encourage local research institutions and pharmaceutical companies to form collaborative drug innovation projects on country- specific diseases, later seeking the financial and technical cooperation of international organisations such as the WHO, UNIDO, MNPCs and transnational research institutions, as well as funding from philanthropic organisations like the Bill & Melinda Gates Foundation. Other open source initiatives in the pharmaceutical sector, such as the Tropical Diseases Initiative,391 TDR Targets,392 Collaborative Drug Discovery393 and the Lilly TB Drug Discovery Initiative,394 could also be examined by LDCs to gain an understanding of their working procedures, and then used to develop more effective open source drug innovation projects targeting the health needs of the LDCs.

  • 395 A social business is a non-loss, non-dividend company designed to address a social objective. Muham (...)

190Further, LDCs such as Bangladesh could devise a different strategy to encourage multinationals to invest in Bangladesh’s pharmaceutical sector under a “social business model”395 as part of their social corporate responsibility and humanitarian goals. Thus, they could help ensure that newly patented drugs, which are necessary but not produced by the Bangladeshi pharmaceutical companies, are available at affordable prices. This could be done either in collaboration with local research institutions or through a joint venture with local pharmaceutical companies. The Government of Bangladesh could provide “special exclusive marketing rights” for pharmaceuticals produced under a social business regime for a certain period and in consultation with the DGDA and prospective investors. In deciding to grant this exclusivity, LDCs could consider factors such as the nature of the investment, the necessity of the medication and the local demand. The exclusivity could be conditional on the requirement that the company continues to provide an adequate supply of the drug at an affordable price.

4.4 Conclusion

191This chapter examined the possible options for legislative change and government interventions for developing countries and LDCs such as Bangladesh by comparing them with the options used in Brazil, India and South Africa. It further explained some of the drawbacks and limitations of existing patent laws. In light of the limitations of patent law, this chapter explored possible government intervention options that could be used to facilitate access to medicines, such as drug price control, national competition law, patent prizes, patent pools, process utility patents, investment protection regimes and social business models.

  • 396 See Bryan Mercurio, ‘Resolving the Public Health Crisis in the Developing World: Problems and Barri (...)
  • 397 Ibid.
  • 398 WHO, ‘Promoting Access to Medical Technologies and Innovation: Intersections between Public Health, (...)
  • 399 Ibid., p. 14.

192This chapter also explored the option of lobbying to extend the transitional period for the introduction of pharmaceutical patents and recommended that developing countries and LDCs reject BITS/FTAs that contain TRIPS-plus provisions that result in the erosion of TRIPS flexibilities. However, a country cannot gain substantial benefits from an extended transitional period or from TRIPS flexibilities unless it has attained a certain level of technological capacity and developed a strong generic pharmaceutical industry.396 Even a compulsory licensing mechanism will be of little use without the technological capability to produce generic pharmaceuticals and a well-developed local pharmaceutical industry.397 Hence, the creation of sound competitive market structures through competition law and enforcement could be more effective both in enhancing access to medical technology and fostering innovation in the pharmaceutical sector.398 This could serve as a corrective tool if IPRs hinder competition and create a potential barrier to innovation and access.399 While adopting a TRIPS-compliant patent law, LDCs need to ensure that their IP protection regimes do not run counter to their public health policies, but are consistent with and supportive of such policies.

Notes

1 See for details, Criteria for Identification and Graduation of LDCs, UN-OHRLLS, http://unohrlls.org/about-ldcs/criteria-for-ldcs

2 GATT, Negotiating Group on TRIPs, ‘Including Trade in Counterfeit Goods’, Meeting of Negotiating Group of 11–13 September 1989, GATT Doc. MTN.GNG/ NG11/15 (26 October 1989), p. 20, https://www.wto.org/gatt_docs/English/ SULPDF/92080131.pdf

3 See Michael Blakeney, Trade Related Aspects of Intellectual Property Rights: A Concise Guide to the TRIPS Agreement (Intellectual Property in Practice) (1998).

4 ‘How to Comply with the TRIPS and WTO Law’, p. 42.

5 See Negotiating Group on TRIPs, ‘Including Trade in Counterfeit Goods’, Meeting of Negotiating Group of 10–21 September 1990, MTN.GNG.NG11/25, p. 8, https://www.wto.org/gatt_docs/English/SULPDF/92110158.pdf

6 TRIPS Agreement, art. 8.2.

7 For example, Brazil implemented a system of compulsory licensing. See ‘The Politics of Patents and Drugs in Brazil and Mexico’, p. 41. India’s experience was very different. It entered the WTO in 1995 and went through a long amendment process to institute a TRIPS-compliant patent regime, which became effective on 1 January 2005. See ‘India’s New “Trips-compliant” Patent Regime’, p. 95. The effect of stronger intellectual patent rights created problems for the larger Indian drug firms and greatly damaged the ability of smaller local firms to meet the rising costs of royalties and remuneration of experienced and efficient pharmacists and other technical people. See ‘Note: Pharmaceutical Patents and TRIPS’, pp. 911, 924–25.

8 For example, the DSB of the WTO established a panel, as requested by the US, to look into the complaint about the patent laws of Brazil in 2001, which the US claimed illegally required the local working of patents and enabled compulsory licensing of the patent, or the authorisation of imports of the patented product (parallel imports), without the authorisation of the patent holder. See WTO, Brazil: Measures Affecting Patent Protection, Dispute Settlement: Dispute DS199, http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds199_e.htm. However, due to massive public pressure and campaigns by public health groups, both parties negotiated it outside the DSB. See ibid. In contrast, Indian patent law was challenged even in the Indian courts by an MNPC, Novartis, claiming that it was inconsistent with some of the provisions of the TRIPS Agreement. Rajshree Chandra, ‘The Role of National Laws in Reconciling Constitutional Right to Health with TRIPS Obligations: An Examination of the Glivec Patent Case in India’, in Incentives for Global Public Health—Patent Law and Access to Essential Medicines, ed. by Thomas Pogge, Mathew Rimmer, and Kim Rubenstein (Yale University, 2010). Another major concern is the confiscation of generic Indian medicines used to treat illnesses such as AIDS and hypertension in several European countries, regarding which India and Brazil complained to the WTO, saying that the European Union (EU) had wrongfully confiscated generic medicines. See Jennifer M. Freedman, ‘India, Brazil Complain at WTO over EU Drug Seizures’, Business Week (12 May 2010), http://web.archive.org/web/20100515054911/http://www.businessweek.com/news/2010-05-12/india-brazil-complain-at-wto-over-eu-drug-seizures-update3-.html (accessed by searching the Internet Archive index).

9 Rochelle C. Dreyfuss, ‘The Role of India, China, Brazil and Other Emerging Economies in Establishing Access Norms and Intellectual Property and Intellectual Property Law Making’ (IICJ Working Paper, 2009), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1442785

10 Susan K. Sell, ‘TRIPS Was Never Enough: Vertical Forum Shifting, FTAS, ACTA and TPP’, Journal of Intellectual Property Law 18 (2011): 447, 476. http://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?article=1186&context=jipl

11 See DPDT, http://www.dpdt.gov.bd

12 See Assessment of the Regulatory Systems (2012).

13 TRIPS Agreement, art. 27.1 (providing that “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application”).

14 See Mohammed El Said, ‘The Implementation Paradox: Intellectual Property Regulation in the Arab World’, Journal of International Trade Law and Policy 9 (2010): 221, 228.

15 Ibid., 229.

16 See ibid., Article 27.1, which reads: Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.

17 Tony VanDuzer, ‘TRIPS and Pharmaceutical Industry in Bangladesh: Towards a National Strategy’ (Paper No. 24, CPD, April 2003), http://www.bdresearch.org/home/attachments/article/nArt/TRIPS_and_the_Pharmaceutical_Industry_in_Bangladesh.pdf. See generally Rajnish Kumar Rai, ‘Patentable Subject Matter Requirements: An Evaluation of Proposed Exclusions to India’s Patent Law in Light of India’s Obligations under the TRIPS Agreement and Options for India’, Chicago-Kent Journal of Intellectual Property 8 (2008).

18 Intellectual Property Rights, The WTO and Developing Countries, p. 56.

19 See Carlos Correa, ‘Guidelines for the Examination of Pharmaceutical Patents: Developing a Public Health Perspective—A Working Paper’ (2006), pp. iv–v, http://ictsd.net/downloads/2008/04/correa_pharmaceutical-patents-guidelines.pdf

20 See Ibid., p. 1.

21 WHO, ‘Public Health, Innovation, and Intellectual Property Rights: Report of the Commission on Intellectual Property Rights, Innovation and Public Health’ (2006) (the “CIPIH Report”), p. 133, http://www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf

22 Commission on Intellectual Property Rights, ‘Integrating Intellectual Property Rights and Development Policy’ (2002), p. 50, http://www.iprcommission.org/papers/pdfs/final_report/CIPRfullfinal.pdf. Clare Short, the then British Secretary of State for International Development, established the Commission on Intellectual Property Rights in May 2001.

23 J.H. Reichman, ‘From Free Riders to Fair Followers: Global Competition under the TRIPS Agreement’, New York University Journal of International Law and Politics 29 (1997): 11, 30.

24 TRIPS Agreement, art. 27.2.

25 See Reichman (1997), p. 93.

26 ‘Product Patents and Access to Medicines in India’, pp. 326, 334.

27 The Patents Act, 1970, § 2(ja), No. 39, Acts of Parliament, 1970 (India).

28 Ibid., § 2(ta).

29 Ibid., § 3(d).

30 The Patents (Amendment) Act, 2005, § 3(b), No. 15, Acts of Parliament, 2005 (India).

31 Ibid., § 3(p).

32 Email Interview with a patent law academic in Delhi, India, 10 March 2012.

33 See generally ‘Trips Compliant Patent Law’, p. 141.

34 In 2001, a draft patent law was prepared by the Law Commission of Bangladesh in consultation with the WIPO. It was not considered until 2007. Meanwhile, for LDCs, the transition period for the introduction of TRIPS-compliant intellectual property law, including patent law, was extended until July 2013, and the obligation to introduce pharmaceutical patents was extended until 1 January 2016. See WTO, Developing Countries’ Transition Periods, ‘Fact Sheet: TRIPS and Pharmaceutical Patents’, http://www.wto.org/english/tratop_e/trips_e/factsheet_pharm04_e.htm. This draft was reviewed lightly in 2007, and was under consideration by the Ministry of Law and Parliamentary Affairs of Bangladesh as the Draft Patents and Designs Act, 2010. It was translated by the Law Commission and Ministry of Law into the national language “Bangla” with little revision and adopted as a separate draft Act in “Bangla” for patents only, as Bangladesh Patent Ain, 2012 (Bangladesh Patent Act, 2012). Unless this draft is approved by the Parliament of Bangladesh, the existing PDA, 1911 will remain in force.

35 Draft Patents and Designs Act, 2010 § 3, 2010 (Bangl.).

36 Ibid., § 4.

37 Ibid., § 5(2).

38 Based on the survey data, this position has been supported by the majority of large, medium and small local pharmaceutical companies in Bangladesh.

39 This has been remarked on by the CEO of an MNPC operating in Bangladesh.

40 Correa (2006), p. 4.

41 Ibid.

42 TRIPS Agreement, art. 29.

43 Ibid.

44 Ibid.

45 See generally Bingbin Lu, ‘Best Mode Disclosure for Patent Applications: An International and Comparative Perspective’, Journal of Intellectual Property Rights 16 (2011): 409, http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1938859

46 PDA, § 4, effective 26 March 1971 by virtue of the Laws Continuation and Enforcement Order of 25 March 1971, and adaptation of Existing Bangladesh Law Order of 1972. The PDA is the same as the Indian PDA (No. II of 1911 (10 Pat. & T.M. Rev. 3697)).

47 Interview with a pharmacist from a leading local pharmaceutical company, in Dhaka, Bangladesh, 3 March 2009.

48 Interview with an examiner at the DPDT, in Dhaka, Bangladesh, 1 March 2009.

49 Lei No. 9.279 art. 24, de 14 de maio de 1996, Diario Oficial Da Uniao [DOU] de 15.05.1996. (Braz.), translated in Brazil: Industrial Property Law, 14/05/1996, No. 9.279, http://www.wipo.int/wipolex/en/details.jsp?id=515

50 The Patents Act, 1970, § 10(4), No. 39, Acts of Parliament, 1970 (India), http://nbaindia.org/uploaded/Biodiversityindia/Legal/14.%20The%20Patents%20Act,%201970.pdf

51 Draft Patents and Designs Act, 2010 § 11, 2010 (Bangl.).

52 See WTO Council for TRIPS, ‘Elements of the Obligation to Disclose the Source and Country of Origin of Biological Resource and/or Traditional Knowledge Used in an Invention’ (IP/C/W/429) 2 (21 September 2004), http://docsonline.wto.org/imrd/directdoc.asp?DDFDocuments/t/IP/C/W429.doc

53 See WTO Public Symposium, ‘Disclosure Requirements: Incorporating the CBD Principles in the TRIPS Agreement on the Road to Hong Kong’ (21 April 2005), p. 1, http://ictsd.org/downloads/2008/12/meeting-report.pdf

54 Tove Iren S. Gerhardsen, ‘Developing Countries Propose TRIPS Amendment on Disclosure’, Intellectual Property Watch (1 June 2006): 1344, http://www.ip-watch.org/2006/06/01/developing-countries-propose-trips-amendment-on-disclosure

55 See WTO Council for TRIPS, Article 27.3(b), ‘Relationship Between the TRIPS Agreement and the CBD, and the Protection of Traditional Knowledge’ (IP/C/W/400/Rev.1), 18 June 2003, http://docsonline.wto.org/imrd/directdoc.asp?DDFDocuments/t/IP/C/W400R1.doc; see also WTO Council for TRIPS, ‘Further Observations by Switzerland on its Proposals Regarding the Declaration of the Source of Genetic Resources and Traditional Knowledge in Patent Applications’ (IP/C/W/433) (25 November 2004), http://docsonline.wto.org/imrd/directdoc.asp?DDFDocuments/t/IP/C/W433.doc

56 Working Group on Reform of the Patent Cooperation Treaty (PCT), WIPO, International Patent Cooperation Union, Proposals by Switzerland Regarding the Declaration of the Source of Genetic Resources and Traditional Knowledge in Patent Applications (PCT/R/WG/4/13) (5 May 2003), http://www.wipo.int/edocs/mdocs/pct/en/pct_r_wg_4/pct_r_wg_4_13.pdf; Working Group on Reform of the Patent Cooperation Treaty (PCT), WIPO, International Patent Cooperation Union, Proposals by Switzerland Regarding the Declaration of the Source of Genetic Resources and Traditional Knowledge in Patent Applications (Doc PCT/R/WG/5/11 Rev.), 19 November 2003, http://www.wipo.int/edocs/mdocs/pct/en/pct_r_wg_5/pct_r_wg_5_11_rev.pdf

57 See WIPO Intergovernmental Committee on Intellectual Property, and Genetic Resources, Traditional Knowledge, and Folklore, Further Observations by Switzerland on Its Proposals Regarding the Declaration of the Source of Genetic Resources and Traditional Knowledge in Patent Applications (WIPO/GRTKF/IC/7/ INF/5) (18 October 2004), http://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_7/wipo_grtkf_ic_7_inf_5.pdf

58 Felix Addor, WTO Public Symposium, ICTSD/CIEL/IDDRI/IUCN/QUNO, ‘Dialogue on Disclosure Requirements: Incorporating the CBD Principles in the TRIPS Agreement On the Road to Hong Kong: Switzerland’s Proposals Regarding the Declaration of the Source of Genetic Resources and Traditional Knowledge in Patent Applications and Switzerland’s views on the Declaration of Evidence of Prior Informed Consent and Benefit Sharing in Patent Applications’ (21 April 2005), p. 5, http://www.iprsonline.org/ictsd/docs/DOO6_Addor.pdf

59 “A number of countries … have already [incorporated] disclosure of origin requirements (in different forms and conditions) in their domestic legislation, including in the Andean Community (Bolivia, Colombia, Ecuador, Peru and Venezuela), Brazil, Costa Rica, Denmark, India, Nepal, Norway and the African Union (53 African countries)”. Disclosure Requirements: Ensuring Mutual Supportiveness Between the WTO TRIPS Agreement and the CBD, ed. by Martha Chouchena-Rojas, Manuel Ruiz Muller, David Vivas, and Sebastian Winkler (IUCN: Gland and Cambridge; International Centre for Trade and Sustainable Development [ICTSD], Geneva, 2005).

60 Interview with an IP lawyer working as a legal adviser and practitioner at the Supreme Court, in Dhaka, Bangladesh, 27 December 2009.

61 See Draft Patent Ain (Law), 2012 § 15, 2012 (Bangl.).

62 ‘TRIPS and Pharmaceutical Industry in Bangladesh’, p. 33.

63 PDA § 4(3), 1911 (Bangl.).

64 Lei No. 9.279 art. 25, de 14 de maio de 1996, Diario Oficial Da Uniao [DOU] de 15.05.1996. (Braz.), translated in Brazil: Industrial Property Law, 14/05/1996, No. 9.279, http://www.wipo.int/wipolex/en/details.jsp?id=515

65 Interview with a pharmaceutical researcher at the University of Dhaka, in Dhaka, Bangladesh, 12 March 2009.

66 TRIPS Agreement, art. 30.

67 Ibid.

68 Mohammad Monirul Azam and Yacouba Sabere Mounkoro, Intellectual Property Protection for the Pharmaceuticals: An Economic and Legal Impacts Study with Special Reference to Bangladesh and Mali, LE GRIOT DU DEVELOPPEMENT § 7.1.2, June 1, 2012, http://legriotdudeveloppement.blogspot.fr/2012/06/intellectual-property-protection-for.html

69 Roche Prods., Inc. v. Bolar Pharm. Co., 733 F. 2d 858 (Fed. Cir. 2006); see Anshull Mittal, ‘Patent Linkage in India: Current Scenario and Need for Deliberation’, Journal of Intellectual Property Rights 15 (2010).

70 Bolar Pharm., 733 F.2d at 861.

71 Ibid., 861–62.

72 Ibid., 862.

73 ‘Patent Linkage in India’, p. 193.

74 See ibid.

75 Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98–417, 98 Stat. 1585 (codified as amended at 15 USC §§ 68(b)–(c), 70(b) (1994); 21 USC §§ 301, 355, 360cc (1994); 28 USC § 2201 (1994); 35 USC §§ 156, 271, 282 (1994)).

76 In the US, this exemption is also technically called the § 271(e)(1) exemption or Hatch–Waxman exemption. K. Suresh Kumar et al., ‘Patent Laws and Research Exemption Imperative—Do Scientists Have Enough Freedom to Operate?’, Current Science 99 (2010): 1488, 1524. The US Supreme Court considered the scope of the Hatch–Waxman exemption in Merck v. Integra, Merck KGaA v. Integra Lifesciences I, Ltd., 545 US 193 (2005):
The Supreme Court held that the statute exempts from infringement
all uses of compounds that are reasonably related to submission of information to the government under any law regulating the manufacture, use or distribution of drugs. In Canada, this exemption is known as the Bolar provision or Roche– Bolar provision, named after the case Roche Products v. Bolar Pharmaceutical. In the European Union, equivalent exemptions are allowed under the terms of EC Directives 2001/82/EC (as amended by Directive 2004/28/EC) and 2001/83/EC (as amended by Directives 2002/98/EC, 2003/63/EC, 2004/24/EC and 2004/27/EC). Research Exemption, Wikipedia, http://en.wikipedia.org/wiki/Research_exemption

77 ‘Intellectual Property Protection for the Pharmaceuticals’; see also Canada—Patent Protection of Pharmaceutical Products: Article 30 of the TRIPS Agreement authorizes limited exceptions to patent rights for such things as research, prior user rights, and pre-expiration testing. Often called the ‘research exception’, the provision is commonly used by countries to advance science and technology by allowing researchers to use a patented invention to gain a better understanding of the technology. In addition, countries also use the provision to allow manufacturers of generic drugs to apply for marketing and safety approval without the patent owner’s permission and before the patent protection expires. The generic producers can then market the drug. This practice, often called the ‘regulatory exception’ or ‘Bolar’ provision, has been upheld as conforming to the TRIPS Agreement. … [The Panel also found] that manufacturing and stockpiling patented drugs prior to the exhaustion of patent protection is not a ‘limited exception’ which can be exempted under Article 30.
Bryan Mercurio, ‘The Impact of the Australia–United States Free Trade Agreement on the Provision of Health Services in Australia’,
Whittier Law Review 26 (2005): 1051, 1065 (footnote and citation omitted).

78 CIPIH Report, p. 24.

79 Mohammed K. El Said, Public Health-related TRIPS-Plus Provisions in Bilateral Trade Agreements: A Policy Guide for Negotiators and Implementers in the WHO Eastern Mediterranean Region (2010), p. 153, http://applications.emro.who.int/dsaf/dsa1081.pdf. See for details, Carlos Correa, Integrating Public Health Concerns into Patent Legislations in Developing Countries (Geneva: South Centre, Chernin du Charnpd’ Anier, pp. 17, 1211, 2000), http://apps.who.int/medicinedocs/pdf/h2963e/h2963e.pdf

80 Ibid. According to Oh and Musungu, “[n]ational laws reviewed in Latin American and Caribbean countries all contained provisions relating to the research or experimental use exception; in Asia, 85% of the national laws reviewed provided for this exception, although the figure is lower in Africa at 59%”. Cecilia Oh and Sisule Musungu, ‘The Use of Flexibilities in TRIPS by Developing Countries: Can They Promote Access to Medicines?’ (Commission on Intellectual Property Rights, Innovation and Public Health [CIPIH], Study 4C), 12 October 2010, http://www.who.int/intellectualproperty/studies/TRIPSFLEXI.pdf

81 El Said, ‘Public Health Related TRIPS-Plus Provisions’; see also ‘Exception to Patent Rights in Developing Countries’, pp. 46, 49.

82 ‘Intellectual Property Protection for the Pharmaceuticals’.

83 Ibid.

84 Draft Patents and Designs Act, 2010 § 48(c), 2010 (Bangl.).

85 See Shamnad Basheer, ‘India’s Tryst with TRIPS: The Patents (Amendment) Act, 2005’, Indian Journal of Law and Technology 1 (2005): 15, 30, http://papers.ssrn.com/sol3/papers.cfm?abstract_id=764066

86 Patent (Amendment Act), 2002, § 107A(a), 2002 (India).

87 During surveys, most local pharmaceutical companies in Bangladesh, irrespective of size, supported this provision.

88 In the survey feedback, MNPCs did not answer this question, but during interviews they opposed the provision and considered that, in the long term, it would provide no benefits for Bangladesh.

89 Interview with an official from a public health NGO, in Dhaka, Bangladesh, 9 February 2009.

90 TRIPS Agreement, art. 28.1(a).

91 TRIPS Agreement, art. 6.

92 WHO, ‘Intellectual Property Protection: Impact on Public Health’, WHO Drug Information 19 (2005): 236, 240, http://apps.who.int/medicinedocs/pdf/s7918e/s7918e.pdf

93 Sudip Chaudhuri, ‘Indian Generic Companies, Affordability of Drugs and Local Production in Africa with Special Reference to Tanzania, IKD’ (Working Paper No. 37, September 2008), http://oro.open.ac.uk/26384/2/

94 Doha Declaration, art. 5(d); Sudip Chaudhuri (2008).

95 See generally Marco C.E.J. Bronckers, ‘The Exhaustion of Patent Rights under World Trade Organization Law’, Journal of World Trade Law 32 (1998): 137–38.

96 N. Lalitha, ‘Doha Declaration and Public Health Issues’, Journal of Intellectual Property Rights 13 (2008): 401, 404, http://nopr.niscair.res.in/bitstream/123456789/2026/1/JIPR%2013(5)%20401-413.pdf

97 Ibid.

98 Ibid.

99 Ibid. A submission to the World Health Organization stated: Article 7 is a key provision that defines the objectives of the TRIPS Agreement. It clearly establishes that the protection and enforcement of intellectual property rights do not exist in a vacuum. They are supposed to benefit society as a whole and do not aim at the mere protection of private rights” and should be utilized in a way for “the mutual advantage of producers and users of technological knowledge; social and economic welfare; and the balance of rights and obligations. Council Discussion on Access to Medicines, TRIPS, Developing Country Group’s Paper—Submission by the Africa Group, Barbados, Bolivia, Brazil, Dominican Republic, Ecuador, Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka, Thailand and Venezuela (IP/C/W/296) 18 (19 June 2001), http://www.wto.org/english/tratop_e/trips_e/paper_develop_w296_e.htm. Therefore: [e]ach provision of the TRIPS Agreement should be read in light of the objectives and principles set forth in Articles 7 and 8. Such an interpretation finds support in the Vienna Convention on the Law of Treaties (concluded in Vienna in 23, May 1969), which establishes, in Article 31, that “[a] treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose”. Ibid., 17.

100 Lalitha (2008).

101 Rohit Malpani, ‘All Costs, No Benefits: How TRIPS-plus Intellectual Property Rules in the US–Jordan FTA Affect Access to Medicines’ (Oxfam Briefing Paper No. 102, 21 March 2007), p. 11, http://www.oxfam.org/sites/www.oxfam.org/files/all costs, no benefits.pdf

102 Integrating Intellectual Property Rights’, p. 52.

103 See CIPIH Report, p. 124.

104 This remark was made by an official from a leading MNPC operating in Bangladesh during an interview, Dhaka, Bangladesh, 1 February 2009.

105 Ibid.

106 Interview with a policy analyst from an international NGO working in Bangladesh, Dhaka, Bangladesh, 1 March 2012.

107 Ibid.

108 See Esther M. Flesch et al., Report Q 156 in the name of the Brazilian Group: International Exhaustion of Industrial Property Rights (XXXVIIIth World Intellectual Property Congress in Melbourne, 23–30 March 2001), https://www.aippi.org/download/commitees/156/GR156brazil.pdf; see also Shamnad Basheer and Mrinalini Kochupillai, ‘TRIPS, Patents and Parallel Imports: A Proposal for Amendment’, Indian Journal of Intellectual Property Law 2 (2009), http://www.nalsar.ac.in/IJIPL/Files/Archives/Volume 2/4.pdf

109 2005 Patent (Amendment) Act, No. 15 § 92(1), 2005 (India).

110 Draft Patent and Designs Act, 2010 § 92, 2010 (Bangl.).

111 Draft Patent Ain (Law), 2012 § 31, 2012 (Bangl.).

112 2005 Patent (Amendment) Act § 107A(b), 2005 (India).

113 ‘TRIPS, Patents and Parallel Imports’, pp. 66–74.

114 See TRIPS Agreement, art. 28.1 (stating in a pertinent part that “a patent owner shall have the exclusive right to prevent third parties not having the owner’s consent from the acts of: making, using, offering for sale, selling, or importing for these purposes that product”).

115 ‘TRIPS, Patents and Parallel Imports’, pp. 84–85.

116 “Exhaustion of rights, or the doctrine of first sale, is inherent to IPRs and a necessity in bringing about legal certainty in downstream markets”. Thomas Cottier, ‘The Exhaustion of Intellectual Property Rights - A Fresh Look’, IIC International Review of Intellectual Property and Competition 39 (2008): 755.

117 See Krithpaka Boonfueng, ‘Parallel Imports in Pharmaceuticals: Increase Access to HIV Drugs’, Thailand Law Forum (2010), http://www.thailawforum.com/articles/hivdrugs1.html

118 ‘The South Africa AIDS Controversy’, p. 12; see also WHA Executive Board Res., WHO, ‘Revised Drug Strategy’ (EB 101/R.24), 2 (27 January 1998), http://apps.who.int/gb/archive/pdf_files/EB101/pdfangl/angr24.pdf

119 TRIPS Agreement, art. 31.

120 Doha Declaration, at 5(b).

121 ‘Intellectual Property Protection for the Pharmaceuticals’; TRIPS Agreement, art. 31.

122 ‘TRIPS and Pharmaceutical Industry in Bangladesh’, p. 36.

123 Ibid.

124 Ibid. (quoting TRIPS Agreement, art. 31). For details, see Swarup Kumar, ‘Compulsory Licensing Provision under TRIPS: A Study of Roche vs Natco Case in India vis-à-vis the Applicability of the Principle of Audi Alteram Partem’, SCRIPT-ed 7.1 (2010).

125 The PDA § 22, 1911 (Bangl.) (emphasis added).

126 See generally F.M. Scherer and Jayashree Watal, ‘Post-TRIPS Options for Access to Patented Medicines in Developing Countries’ (Working Paper Series, Paper No. WG4:1, Commission on Macroeconomics and Health [CMH]), http://library.cphs.chula.ac.th/Ebooks/HealthCareFinancing/WorkingPaper_WG4/WG4_1.pdf

127 The PDA § 23(3), 1911 (Bangl.).

128 Interview with a deputy registrar from the DPDT, in Dhaka, Bangladesh, 7 March 2012.

129 See generally ‘The Use of Flexibilities in TRIPS by Developing Countries’.

130 2005 Patent (Amendment) Act § 92(1), 2005 (India).

131 Ibid., § 92A (emphasis added).

132 Ibid., § 83 (emphasis added).

133 TRIPS Agreement, arts. 7–8.

134 ‘Product Patents and Access to Medicines in India’, pp. 326, 341.

135 Lei No.9.279 art. 71, de 14 de maio de 1996, Diario Oficial Da Uniao [DOU] de 15.05.1996. (Braz.), translated in Brazil: Industrial Property Law, 14/05/1996, No. 9.279, http://www.wipo.int/wipolex/en/details.jsp?id=515 (emphasis added).

136 Brazil used this provision to threaten compulsory licenses to gain substantial price reductions on several occasions. See ‘Fault Lines in the World Trade Organization’.

137 Draft Patents and Design Act, 2010, § 84, 2010 (Bangl.).

138 Although it is not clarified in the Draft Patents and Design Act, 2010, the Draft Patent Ain, 2012 under section 14(18) provides that compulsory licenses can be granted for pharmaceutical exports to countries having inadequate or no manufacturing capacity. However, the draft law of 2012 included a separate provision in section 30 stipulating that compulsory licenses including pharmaceutical export licenses could not be granted in Bangladesh unless the 30 August TRIPS amendment becomes effective in Bangladesh; see Draft Patent Act, 2012 and Azam, ‘Globalising Standard of Patent Protection in WTO Law and Policy Options for the LDCs’, Chicago-Kent Journal of Intellectual Property, 13.2 (2014).

139 ‘Integrating Intellectual Property Rights’, p. 8.

140 CIPIH Report, p. 176.

141 “The Human Development Index (HDI) is a measure of life expectancy, literacy, education, and standard of living for countries worldwide. It is a standard means of measuring well-being, especially child welfare”. Centre for Environment Education, Sustainable Development: An Introduction 17 (2007). The HDI is used to determine whether the country is a developed, a developing or an under- developed country, and to measure the effect of economic policies on quality of life (Ibid.). The origins of the HDI are found in the annual Human Development Reports of the UNDP; Sakiko Fukuda-Parr, ‘The Human Development Paradigm: Operationalizing Sen’s Ideas on Capabilities’, Feminist Economics 9 (2003): 301, 303. It was devised by economist Mahabub-ul Haq in 1990 with the explicit purpose of shifting “the focus of development economics from national income accounting to people centered policies” (ibid., citation omitted). For more information, see Human Development Index (HDI), Human Development Reports, UNDP, http://hdr.undp.org/en/statistics/hdi

142 According to James Love: In 2005, Canada proposed royalty guidelines for the export of medicines under the Jean Chrétien Pledge to Africa Act, which implements the WTO waiver of Article 31(f) of the TRIPS Agreement. The Canadian royalty guidelines are a sliding scale of the generic sales price. The rate depends entirely upon the location of the importing market and the rank of the importing country in the [United Nations Human Development Index] (UNHDI). The formula is one, plus the number of countries on the UNHDI, minus the importing country’s rank on the UNHDI, divided by the number of countries on the UNHDI, multiplied by 0.04. The rate is then applied to the generic sales price. With 177 countries currently in the UNHDI index, the royalty rate can be expressed as: Royalty rate= 0.04 × [(178) – rank importing country]/177. (James Love, ‘Remuneration Guidelines for Non-voluntary Use of a Patent on Medical Technologies’ (2005), p. 72, http://www.who.int/medicines/areas/technical_cooperation/WHOTCM2005.1_OMS.pdf.) During the time of adoption of this royalty approach in 2004, the top rate was 4% of the generic sales price for Norway, as it was the number one country in the HDI in 2004, and the lowest rate was 0.02% for Sierra Leone as the lowest ranking country in the HDI in 2004 (ibid.). See for details, Mohammad Monirul Azam, ‘Revisiting the Climate Change Negotiation under the UNFCCC: In Search of Effective Framework for Negotiation and Technology Transfer’ (2009), http://www.conference.unitar.org/yale/sites/conference.unitar.org.yale/files/Paper_Azam.pdf

143 The ranking of Bangladesh in the HDI of 2010 was 129. UNDP, ‘Human Development Report 2010, The Real Wealth of Nations: Pathways to Human Development’ (2010), p. 145, http://hdr.undp.org/sites/default/files/reports/270/hdr_2010_en_complete_reprint.pdf. For the HDI of other countries, see ibid., pp. 143–46.

144 The PDA § 23, 1911 (Bangl.).

145 Ibid.

146 2005 Patent (Amendment) Act § 84, 2005 (India): Compulsory licences. –
(1) At any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory licence on patent on any of the following grounds, namely –(a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or (b) that the patented invention is not available to the public at a reasonably affordable price, or (c) that the patented invention is not worked in the territory of India.

147 Lei No.9.279 art.68, de 14 de maio de 1996, Diario Oficial Da Uniao [DOU] de 15.05.1996. (Braz.), translated in Brazil: Industrial Property Law, 14/05/1996, No. 9.279, http://www.wipo.int/wipolex/en/details.jsp?id=515:
(1) The following also occasion a compulsory license:
I. non-exploitation of the object of the patent within the Brazilian territory for failure to manufacture or incomplete manufacture of the product, or also failure to make full use of the patented process, except cases where this is not economically feasible, when importation shall be permitted; or
II. commercialization that does not satisfy the needs of the market.

148 See generally ‘India, the Pharmaceutical Industry and the Validity of TRIPS’; see also Daya Shanker, ‘Brazil, Pharmaceutical Industry and the WTO’, Journal of World Intellectual Property 5 (2002): 53.

149 Compulsory License Application No. 1 of 2011, Application for Compulsory License Under Section 84(1) of the Patents Act, 1970 in Respect of Patent No. 215758, Natco Pharma Ltd. v. Bayer Corp. (9 March 2012), http://www.ipindia.nic.in/iponew/compulsory_license_12032012.pdf

150 Ibid., pp. 39–45.

151 Ibid., p. 43.

152 During interviews, compulsory licensing was supported by most of the executives of local pharmaceutical companies, irrespective of size. That support was echoed by public health NGOs and local researchers.

153 Interview with a policy analyst from an MNPC operating in Bangladesh, in Dhaka, Bangladesh, 9 March 2012.

154 Interview with a policy analyst from an international NGO working in Bangladesh, in Dhaka, Bangladesh, 10 March 2012.

155 ‘Public and Private Sector Approaches’.

156 This was mentioned by representatives from a number of large, medium and small pharmaceutical companies in Bangladesh, and was supported by officials at the Patent Office and DGDA, Bangladesh.

157 Interview with the CEO of an MNPC operating in Bangladesh, in Dhaka, Bangladesh, 9 March 2012.

158 Lei No.9.279 art. 45, de 14 de maio de 1996, Diario Oficial Da Uniao [DOU] de 15.05.1996. (Braz.), translated in Brazil: Industrial Property Law, 14/05/1996, No. 9.279, http://www.wipo.int/wipolex/en/details.jsp?id=515

159 ‘Pharmaceutical Patent Protection’, pp. 1, 8.

160 The PDA § 9(1)), 1911 (Bangl.) (emphasis added).

161 Azam and Richardson (2010a), p. 8.

162 Ibid.

163 Ibid.

164 Ibid., 8.

165 Ibid.; see also The Patent Opposition System in India, p. 14.

166 Azam and Richardson (2010a), pp. 8–9.

167 During interviews, this view was echoed by most of the officials of pharmaceutical companies in Bangladesh, irrespective of size, and was also supported by local IP academics and public health NGOs.

168 Interview with an IP academic from the University of Chittagong, in Chittagong, Bangladesh, 5 March 2012.

169 Ibid.

170 Interview with the CEO of an MNPC operating in Bangladesh, in Dhaka, Bangladesh, 7 March 2012.

171 Lei No.9.279 art. 40, de 14 de maio de 1996, Diario Oficial Da Uniao [DOU] de 15.05.1996. (Braz.), translated in Brazil: Industrial Property Law, 14/05/1996, No. 9.279, http://www.wipo.int/wipolex/en/details.jsp?id=515 (“An invention patent shall remain in force for a period of 20 (twenty) years, and a utility model patent for a period of 15 (fifteen) years from the date of filing”).

172 2005 Patent (Amendment) Act, § 53(1), 2005 (India).

173 From interview data (this has been supported by many large, medium and small local pharmaceutical companies in Bangladesh).

174 Interview with an executive from an MNPC operating in Bangladesh, in Dhaka, Bangladesh, 9 March 2012.

175 See Emily Jones, ‘Signing Away the Future: How Trade and Investment Agreements Between Rich and Poor Countries Undermine Development’ (Oxfam Briefing Paper No. 101, March 2007), http://www.oxfam.org/sites/www.oxfam.org/files/Signing Away the Future.pdf

176 Ibid.

177 El Said (2010), p. 145.

178 Ibid.; see also ‘US FTA May Cost Drug Industry $ 1.2 Billion: Gov’t’, the hankyoreh, 17 October 2006, http://english.hani.co.kr/arti/english_edition/e_business/165065.html

179 El Said, p. 144; see ‘Resource Book on TRIPS and Development’. It should be noted that patent term extensions were proposed by the developed countries and rejected by the developing countries during the Uruguay Round.

180 CIPIH Report, p. 182.

181 See generally ‘Global Communication on HIV and the Law, Regional Issues Brief: Intellectual Property Rights and Access to Medicines’ (17 February 2011), p. 22, http://www.hivlawcommission.org/resources/aprd/IssuesBrief_IPR.pdf. For example: In 2008, Kenya enacted its Anti-counterfeit Act, purportedly designed to address the problem of counterfeit goods, including substandard and spurious medicines. It attached harsh criminal sanctions related to counterfeiting. However, according to the definition of the Act safe, effective and legitimate generic medicines were also considered “counterfeit”. By conflating the issues of safety, quality and efficacy, and the separate field of intellectual property, the Act potentially criminalized the manufacture, import, export, possession or sale of perfectly safe generic medicines. Kenya’s Anti-counterfeit Act was challenged before the High Court in July 2009 by three petitioners living with HIV on the basis that impinges on their constitutional right to health. The Court passed preliminary judgment in favour of petitioners on 23 April, 2010 and suspended powers of Anti-counterfeit Agency to interfere with importation and distribution of generics pending ruling on the substance. UNDP, ‘Good Practice Guide: Improving Access to Treatment by Utilizing Public Health Flexibilities in the WTO TRIPS Agreement’ (2010), p. 47, http://content.undp.org/go/cms-service/stream/asset/?asset_id=3259443

182 See generally Ermias Biadgleng and Viviana Tellez, ‘The Changing Structure and Governance of Intellectual Property Enforcement’ (South Centre Research Paper No. 15, January 2008), http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1210622; Susan Sell, ‘The Global IP Upward Ratchet, Anti-counterfeiting and Piracy Enforcement Efforts: The State of Play’ (PIJIP Research Paper Series. No. 15, American University Washington College of Law, 2010), http://digitalcommons.wcl.american.edu/research/15

183 See generally Carlos Correa, Centre for Interdisciplinary Studies on Industrial Property and Economics, ‘The Push for Stronger Enforcement Rules: Implications for Developing Countries’ (2007); Michael Blakeney, ‘International Proposals for the Criminal Enforcement of Intellectual Property Rights: International Concern with Counterfeiting and Piracy’, Intellectual Property Q.1 (2009).

184 UNDP, p. 46.

185 Ibid.; see Henning Grosse Ruse-Khan and Thomas Jaeger, ‘Policing Patents Worldwide? EC Border Measures Against Transiting Generic Drugs Under EC and WTO Intellectual Property Regimes’, International Review of Intellectual Property and Competition Law, 40 (2009): 502; see also Eye on the Ball Medicine Regulation.

186 UNITAID is the first global health organisation that “uses innovative financing to increase funding for greater access to treatments and diagnostics for HIV/AIDS, malaria and tuberculosis in low-income countries”. About Unitaid, UNITAID, http://www.unitaid.eu/en/who/about-unitaid. It is “[b]ased in Geneva and hosted by the World Health Organization, approximately half of UNITAID’s finances come from a levy on air tickets”. It was “established in 2006 by the governments of Brazil, Chile, France, Norway and the United Kingdom as the ‘International Drug Purchasing Facility’” (Ibid.). It is now backed by an expanding north-south membership, including Cyprus, Korea, Luxembourg, Spain, Cameroon, Congo, Guinea, Madagascar, Mali, Mauritius and Niger, along with philanthropic organisations like the Bill and Melinda Gates Foundation.

187 See Frederick M. Abbott, ‘Seizure of Generic Pharmaceuticals in Transit Based on Allegations of Patent Infringement: A Threat to International Trade, Development and Public Welfare’, WIPO Journal 1 (2009): 43–50, https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1535521

188 The International Medical Products Anti-counterfeiting Taskforce (IMPACT) is a global coalition of stakeholders including NGOs, enforcement agencies, pharmaceutical manufacturers associations, and drug and regulatory authorities. IMPACT, Summary Report for Third IMPACT General Meeting (3–5 December 2008), http://apps.who.int/impact/resources/IMPACTthirdgeneralmeeting_report.pdf

189 For details, see ‘Access to Indian Generic Drugs: Emerging Issues’, pp. 225–52.

190 See Why did the Government of India oppose the ‘counterfeit drug’ definition proposed by IMPACT?’, http://spicyip.com/2009/03/why-did-government-of-india-oppose.html

191 See WHO, Counterfeit Drugs. Guidelines for the development of measures to combat counterfeit drugs, http://apps.who.int/medicinedocs/en/d/Jh1456e/

192 See TRIPS Agreement, art. 61. It states: Members shall provide for criminal procedures and penalties to be applied at least in cases of wilful trademark counterfeiting or copyright piracy on a commercial scale. Remedies available shall include imprisonment and/or monetary fines sufficient to provide a deterrent, consistently with the level of penalties applied for crimes of a corresponding gravity. In appropriate cases, remedies available shall also include the seizure, forfeiture and destruction of the infringing goods and of any materials and implements the predominant use of which has been in the commission of the offence. Members may provide for criminal procedures and penalties to be applied in other cases of infringement of intellectual property rights, in particular where they are committed wilfully and on a commercial scale.

193 See ‘Access to HIV/AIDS Treatment in Developing Countries’, Interagency Coalition on AIDS and Development (August 2001), http://www.icad-cisd.com

194 Interview with officials at the DGDA and public health NGOs, in Dhaka, Bangladesh, 12–15 March 2012.

195 Make Vital Medicine Available for People, p. 5.

196 Ibid.

197 Ibid.

198 Ibid.

199 Quoted in Make Vital Medicine Available for People.

200 Email interview with a patent law academic, in New Delhi, India, 11 March 2012.

201 Make Vital Medicine Available for People, p. 6.

202 Ibid.

203 Ibid.

204 See generally, World Health Organization (WHO), Drugs and Money Prices, Affordability and Cost Containment, ed. by M.N.G. Dukes, C.P. de Joncheere et al. (2003) http://www.euro.who.int/__data/assets/pdf_file/0011/96446/e79122.pdf

205 Amit Sen Gupta, ‘Should Drug Prices be Controlled?’, Economic Times (6 August 2002), http://articles.economictimes.indiatimes.com/2002-08-06/news/27340990_1_drug-prices-price-controls-drug-companie

206 Jan Swasthya Abhiyan, National Coordination Committee, ‘Access to Essential Medicines’, p. 37 (February 2007), http://www.healthpolicy.cn/rdfx/jbywzd/gjjy2/yd/yjwx/201002/P020100227572014659949.pdf. See generally Jon Sussex, Koonal K Shah and Jim Butler, ‘The Publicly Funded Vaccines Market in Australia’ (Consulting Report No. 10/02, Office of Health Economics [OHE], 25 October 2010).

207 The pharmaceutical price regulation scheme regulates profits to within 17–21% on historic capital or the initial capital used to begin the venture, with 25% variation on either side. Companies are free to set prices, provided the rate of return is within the regulation band. If the profits are higher, the companies have to reduce them the next year, and if they are lower they can raise their prices. For details, see Kevin A Hassett, Price Controls and the Evolution of Pharmaceutical Markets (American Enterprise Institute, 2004), http://www.who.int/intellectualproperty/news/en/Submission-Hassett.pdf

208 See Alan Maynard and Karen Bloor, ‘Dilemmas in Regulation of the Market for Pharmaceuticals’, Health Affairs 22.3 (2003).

209 See Azam and Richardson (2010b).

210 See Study on the Viability of High Quality Drugs Manufacturing.

211 No drug can be introduced into the market without prior approval from the Drug Control Committee and price fixation by the Drug Price Committee as per the DCO 1982 § 9(2), 1982 (Bangl.).

212 DCO 1982, § 6(1) (Bangl.).

213 See Study on the Viability of High Quality Drugs Manufacturing.

214 Interview with an official from the DDA, in Dhaka, Bangladesh, 26 February 2012.

215 See Sanjay Kathuria and Mariem Mezghenni Malouche, Toward New Sources of Competitiveness in Bangladesh: Key Insights of the Diagnostic Trade Integration Study, https://openknowledge.worldbank.org/handle/10986/22712

216 Ibid.

217 DCO 1982, § 4(2) (Bangl.).

218 Interview with a policy analyst from an international public health NGO, in Dhaka, Bangladesh, 23 February 2012.

219 Make Vital Medicine Available for People, p. 4.

220 Ibid.

221 Ibid.

222 Interview with public health NGOs and pharmaceutical researchers, in Dhaka, Bangladesh, 12 March 2012.

223 Ibid.

224 Interview with a public health activist, in Dhaka, Bangladesh, 23 December 2009.

225 Ibid.

226 See About PMPRB, Patented Medicine Prices Review Board, http://www.pmprb-cepmb.gc.ca/about-us

227 Ibid.

228 Ibid.

229 Ibid.

230 Ibid.

231 The surveys indicated that 50% of pharmaceutical companies operating in Bangladesh strongly agreed with the withdrawal of price control and 27% also agreed with the withdrawal (this represents all multinational, large and medium- sized companies that participated in the survey). In contrast, 18% strongly disagreed and 5% disagreed with the proposition (all of them small pharmaceutical companies).

232 Interview with an official from a large local pharmaceutical company, in Dhaka, Bangladesh, 13 March 2012.

233 This view of large pharmaceutical companies was also supported by an official from a medium-sized local pharmaceutical company during an interview, in Dhaka, Bangladesh, 13 March 2012.

234 Interview with the CEO of a local pharmaceutical company, in Dhaka, Bangladesh, 28 December 2009 (confirming the notion that small pharmaceutical companies support price control measures because they derive greater benefits, given their low production range, which is limited to certain products only).

235 Interview with an official from BAPI, in Dhaka, Bangladesh, 23 January 2009.

236 Interviews with IP academics and public health activists, in Dhaka, Bangladesh, 14 March 2012.

237 Interview with a deputy registrar from the DPDT, in Dhaka, Bangladesh, 22 January 2009.

238 Ibid.

239 The DCO was first passed in 1970 and then revised in 1979, 1987 and 1995. See for details, ‘National Pharmaceuticals Pricing Policy, 2012’, http://apps.who.int/medicinedocs/en/d/Js20106en. See also, Government of India, National Pharmaceutical Pricing Authority, http://www.nppaindia.nic.in/index1.html

240 ‘Recommendations of the Task Force Constituted Under the Chairmanship of Proneb Sen to Explore Issues Other than Price Control to Make Available Life- saving Drugs at Reasonable Prices’ (2005), http://www.drugscontrol.org/pdf/f_recom2005.pdf

241 Ibid., 1.1.

242 Ibid., 1.2.

243 Ibid., 1.5.

244 Taskforce to Explore Options, pp. 53–54.

245 Interview with a public health activist and policy analyst working with a public health-based international NGO, in Dhaka, Bangladesh, 11 February 2012.

246 Interview with an IP lawyer working as an in-house legal counsel and regulatory affairs adviser at a local pharmaceutical company, in Dhaka, Banglesh, 13 February 2012.

247 A.K. Monaw-war Uddin Ahmad, ‘Competition, Regulation and the Role of the State: The Case of Bangladesh’, Journal of Asiatic Society of Bangladesh 53 (2008): 199, 211.

248 Fiona M. Scott Morton, ‘The Problems of Price Controls’, Regulation (2001), p. 50, http://object.cato.org/sites/cato.org/files/serials/files/regulation/2001/4/morton.pdf

249 Ibid.

250 Ibid., p. 53.

251 See Patricia Danzon and Michael Furakawa, ‘Prices and Availability of Pharmaceuticals’, Health Affairs 27 (2005): 221, 225.

252 See generally Wendy J. Werner, ‘Micro-insurance in Bangladesh: Risk Protection for the Poor?’, Journal of Health, Population and Nutrition 27 (2009): 563, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2928102/pdf/jhpn0027-0563.pdf

253 For example, in the UK, “public health and insurance takes care of 83.4 percent of the spending on medicine, and in Germany, it is 78.5 percent”. S. Narayan, ‘Some Approaches to Pricing Controls for Patented Drugs in India’, ISAS Insights 41 (1 December 2008): 1, 2, http://mercury.ethz.ch/serviceengine/Files/ISN/94707/ipublicationdocument_singledocument/f8515305-e6a3-4b13-9ba4-27d9ba38b937/en/42.pdf

254 Interview with patent lawyers and pharmaceutical researchers, in Dhaka, Bangladesh, 14 March 2012.

255 Interview with public health activists, in Dhaka, Bangladesh, 16 March 2012. All activists supported the notion that MNPCs operating in Bangladesh are not interested in supplying products in the local market that are under price control and have low profit margins.

256 Sislu F. Musungu, Susan Villanueva and Roxana Blasetti, Utilizing TRIPS Flexibilities for Public Health Protection through South-South Regional Framework (South Centre, 2004), http://www.iprsonline.org/resources/docs/trips-health-southcentre2004.pdf

257 TRIPS Agreement, art. 8.2; see ibid., art. 30; Thomas Cottier and Ingo Meitinger, ‘The TRIPS Agreement without a Competition Agreement’ (Paper presented at the Trade and Competition in the World Trade Organization [WTO] and Beyond, Venice, 4–5 December 1998).

258 ‘The Ability of Select Sub-Saharan Africa Countries to Utilize TRIPS Flexibilities and Competition Law’, pp. 2–4.

259 The World Bank, ‘World Development Report: Building Institutions for Markets’ (2002), p. 147, https://openknowledge.worldbank.org/handle/10986/5984

260 In Brazil, a competition law, Law No. 8,884/94, was replaced by an updated Competition Act, Law No. 12,529/11, which came into force on 29 May 2012. Ana Paula Martinez, ‘Abuse of Dominance: The Third Wave of Brazil’s Antitrust Enforcement?’, Competition Law International 9 (2013): 169, 170. Article 1 of the Brazilian competition law states that the statute’s objective is to set out “antitrust measures in keeping with such constitutional principles as free enterprise and open competition, the social role of property, consumer protection, and restraint of abuses of economic power”. Federal Law No. 8,884 of 11 June 1994 (Braz.).

261 In India, the Competition Act was enacted in 2002 to replace the Monopolies and Restrictive Trade Practices (MRTP) Act, 1969. Terry Calvani and Karen Alderman, ‘BRIC in the International Merger Review Edifice’, Cornell International Law Journal 43 (2010): 73, 74. It established the Competition Commission of India to “eliminate practices having adverse effect on competition, to promote and sustain competition, protect the interests of consumers and ensure freedom of trade carried on by other participants” in markets. Vinod Dhall, ‘Competition Law in India’, Antitrust 21-SPG (2007): 73.

262 See generally Carina Smit, The Rationale for Competition Policy: A South African Perspective (2005), http://econex.co.za/wp-content/uploads/2015/04/econex_researcharticle_10.pdf

263 Medicines and Related Substances Control Amendment Act.

264 Ibid., § 15C.

265 According to Court Case Between 39 Pharmaceutical Firms and The South African Government, CPTech, http://www.cptech.org/ip/health/sa/pharma-v-sa.html: A group of 39 pharmaceutical companies has dropped its lawsuits against the government of South Africa. They had taken South Africa to court over its Medicines and Related Substances Act. The main issue was Amendment 15(c) which would allow TRIPS-compliant compulsory licensing and parallel imports of medicines in South Africa. The suit was first filed on February 18, 1998. On March 6, 2001, the South African court hearing the case ruled that the Treatment Access Campaign (TAC) would be granted a friend of the court role. It also adjourned the case until April 18, bowing to threats from the PMA to file an appeal on the grounds that they needed additional time to response [sic] to the new evidence and issues raised by TAC. On April 19, 2001, the pharmaceuticals companies, under an extremely high amount of international pressure, dropped their case.

266 See Competition Commission Finds Pharmaceutical Firms.

267 Ibid.

268 ‘Access to Patented Anti-HIV/AIDS Medicine’.

269 Ibid.

270 ‘Will Bangladesh’s New Competition Law Prove Effective?’.

271 Quoted in Will Bangladesh’s New Competition Law Prove Effective?’.

272 Karen Ellis Rohit Singh, Shaikh Eskander, and Iftekharul Huq, Assessing the Economic Impact of Competition: Findings from Bangladesh (ODI, 2010), http://www.odi.org.uk/sites/odi.org.uk/files/odi-assets/publications-opinion-files/6058.pdf

273 Ibid., p. 2.

274 Ibid.

275 Shakhawat Hossain, ‘No Enforcement of Laws on Food Adulteration, Children, Fair Trade’, New Age (Dhaka) (19 May 2014), http://newagebd.net/12634/no-enforcement-of-laws-on-food-adulteration-children-fair-trade/#sthash.IMYI3 DvK.dpuf

276 ‘The Ability of Select Sub-Saharan Africa Countries’, p. 6.

277 See Intellectual Property and Competition Law: Exploration of Some Issues.

278 See ibid., pp. 13–19. In fact, these patents should never have been granted in the first place. Lack of proper resources, expertise and proper examination in the LDCs may allow for such fraudulent registrations. In these situations, competition law plays an important role.

279 See ibid., pp. 13–16.

280 Interview with an IP academic from the University of Chittagong, in Chittagong, Bangladesh, 18 January 2012.

281 Interview with a public health activist, in Dhaka, Bangladesh, 23 January 2012.

282 See Joseph E. Stiglitz, ‘Scrooge and Intellectual Property Rights’, British Medical Journal 333 (2006): 1279–80; see also Joseph E. Stiglitz and Arjun Jayadev, ‘Medicine for Tomorrow: Some Alternative Proposals to Promote Socially Beneficial Research and Development in Pharmaceuticals’, Journal of Generic Medicines 7(3): pp. 217–26.

283 William W. Fisher and Talha Syed, ‘A Prize System as a Partial Solution to the Health Crisis in the Developing World’ (Discussion Paper No. 5, Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School, 2009), https://www.law.berkeley.edu/files/Fisher_Prizes12.pdf

284 See generally Mayer Brezis, ‘Big Pharma and Health Care: Unsolvable Conflict of Interests Between Private Enterprise and Public Health’, Israel Journal of Psychiatry and Related Sciences 45 (2008): 83, http://publichealth.doctorsonly.co.il/wp-content/uploads/2011/12/2008_2_3.pdf

285 Marlynn Wei, ‘Should Prizes Replace Patents? A Critique of the Medical Innovation Prize Act of 2005’, Boston University Journal of Science and Technology Law 13.1 (2007), http://www.bu.edu/law/central/jd/organizations/journals/scitech/volume131/documents/Wei_WEB.pdf

286 Michael Polanvyi, ‘Patent Reform’, Review of Economic Studies 11 (1944): 61, 65 (emphasis omitted).

287 ‘Should Prizes Replace Patents?’, p. 29 (footnote omitted).

288 Ibid.

289 Ibid., p. 31.

290 See generally Lee N. Davis, Should We Consider Alternative Incentives for Basic Research? Patents vs. Prizes (Paper presented at the DRUID Summer Conference, 6–8 June 2002), http://www.druid.dk/conferences/summer2002/Papers/DAVIS.pdf

291 Michael Abramowicz, ‘Perfecting Patent Prizes’, Vanderbilt Law Review 56 (2003): 115, 121.

292 See generally Should We Consider Alternative Incentives for Basic Research?

293 ‘Should Prizes Replace Patents?’, p. 26 (footnote omitted). Many authors have criticised the growing numbers of “me-too” drugs on the market, products that duplicate the therapeutic value of already existing drugs. See Aidan Hollis, ‘An Efficient Reward System for Pharmaceutical Innovation’ (10 June 2004) (unpublished manuscript), p. 6, http://www.who.int/intellectualproperty/news/Submission-Hollis6-Oct.pdf; Youngme E. Moon and Kerry Herman, Marketing Antidepressants: Prozac and Paxil (Harvard Business School Case 502-055, October 2005). For an argument favourable towards “me-too” drugs for creating competition, see Thomas H. Lee, ‘“Me-too” Products: Friend or Foe?’, New England Journal of Medicine 350 (2004).

294 ‘Should Prizes Replace Patents?’, p. 26. Only 10% of the world’s expenditure on R&D is spent on targeting 90% of the disease burden (citing Amy Kapczynski Samantha Chaifetz, Zachary Katz and Yochai Benkler, ‘Addressing Global Health Inequities: An Open Licensing Approach for University Innovations’, Berkeley Technology Law Journal 20 (2005)).

295 ‘Should Prizes Replace Patents?’, pp. 26–27 (footnotes omitted).

296 Ibid., p. 28 (footnotes omitted).

297 Ibid., p. 34; see also ‘A Prize System as a Partial Solution’.

298 ‘Proposal by Bolivia, Suriname and Bangladesh: Prizes as a Reward Mechanism for New Cancer Treatments and Vaccines in Developing Countries’ (15 April 2009), p. 1, http://www.who.int/phi/Bangladesh_Bolivia_Suriname_CancerPrize.pdf. The proposal stated: According to the WHO, of the more than 8 million persons who died from cancer in 2008, 5.7 million, or 71 percent, lived in developing countries. Cancer is a leading cause of death worldwide. According to the WHO, the percentage of total deaths attributed to cancer is expected to decline in developed countries, but to increase in all developing country regions.
See also Krista L. Cox, ‘The Medicines Patent Pool: Promoting Access and Innovation for Life-saving Medicines through Voluntary Licenses’,
Hastings Science and Technology Law Journal 4 (2012): 291.

299 ‘Proposal by Bolivia, Suriname and Bangladesh’, p. 2.

300 Ibid.

301 Ibid.

302 Ibid.

303 Ibid. (emphasis omitted).

304 Ibid., p. 3; see also TRIPS Agreement, arts. 30, 31, 44.

305 CPTech, Proposal for Treaty on Medical Research and Development’ (February 2005), http://www.cptech.org/workingdrafts/rndtreaty.html

306 Ibid.

307 Andrew Farlow, ‘A Global Medical Research and Development Treaty: An Answer to Global Health Needs?’ (2007) (IPN Working Paper on Intellectual Property, Innovation and Health), p. 12, http://www.andrewfarlow.com/global_medical_research_treaty.pdf; see WHO, ‘[Global Framework on] Essential Health Research and Development’, in Executive Board, 117th Session, Resolutions, Decisions, and Annexes (27 January 2006), p. 20, http://apps.who.int/gb/ebwha/pdf_files/EB117-REC1/B117_REC1-en.pdf

308 Ryan Abbot, ‘Potential Elements of the WHO Global R&D Treaty: Tailoring Solutions for Disparate Contexts’, Intellectual Property Watch (29 January 2013), https://www.ip-watch.org/2013/01/29/potential-elements-of-the-who-global-rd-treaty-tailoring-solutions-for-disparate-contexts/

309 Ibid.

310 WHO, ‘Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination’ (5 April 2012), http://www.who.int/phi/CEWG_Report_5_April_2012.pdf

311 WHO Tackles Intellectual Property, R&D Treaty’, Bridges Weekly Trade News Digest (27 May 2009): 1, 3, http://www.ictsd.org/sites/default/files/review/bridgesweekly/bridgesweekly13-19.pdf

312 See James Love, ‘WHO negotiators propose putting off R&D treaty discussions until 2016’, Knowledge Ecology International (KEI) (28 November 2012, 8:22 PM), http://keionline.org/node/1612

313 Ibid.

314 Based on interview responses from pharmaceutical academics and researchers.

315 Carlos M. Correa, Protecting Test Data for Pharmaceutical and Agrochemical Products under Free Trade Agreements, UNCTAD-ICTSD Dialogue on Moving the Pro- development IP Agenda Forward: Preserving Public Goods in Health, Education and Learning (United Nations Conference on Trade and Development [UNCTAD], 29 November to 3 December 2004), http://www.iprsonline.org/unctadictsd/bellagio/docs/Correa_Bellagio4.pdf

316 “Data exclusivity was first introduced in 1987 in a number of European countries to compensate for insufficient product patent protection. However, product patents for twenty years are now available in all 27 EU member states. The rules on data exclusivity have been changed in the EU pharmaceutical laws adopted in 2004”. Public Health Related TRIPS-Plus Provisions, p. 186.

317 Data Exclusivity, European Generic Medicines Association, http://www.cptech.org/ ip/health/dataexcl

318 ‘Integrating Intellectual Property Rights’, p. 62.

319 Animesh Sharma, ‘Data Exclusivity with Regard to Clinical Data’, The Indian Journal of Law and Technology 3 (2007): 82–104, http://ijlt.in/wp-content/uploads/2015/08/Sharma-Data-Exclusivity-with-regard-to-Clinical-Data-3-Indian-J.-L.-Tech.-82.pdf

320 Ibid., p. 84.

321 Article 39.3 of the TRIPS Agreement states: Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.

322 Sudip Chaudhuri, ‘TRIPS and Changes in Pharmaceutical Patent Regime in India’ (Indian Institute of Management Calcutta, Working Paper No. 535, January 2005), p. 19.

323 Ibid.

324 Ibid.

325 Ibid.; see TRIPS Agreement, art. 39.3.

326 Sudip Chaudhuri, p. 19.

327 Ibid.

328 Ibid., 20.

329 WHO, Intellectual Property Rights and Access to Medicines: A South-East Asia Perspective on Global Issues (2008), http://apps.searo.who.int/pds_docs/B3468.pdf

330 CIPIH Report, p. 126.

331 In the surveys, representatives from all the local pharmaceutical companies, regardless of their size, supported the Indian position, whereas one MNPC supported test data protection, and the other MNPCs did not disclose their position on the issue.

332 Ibid.

333 Interview with an academic from the University of Dhaka, in Dhaka, Bangladesh, 13 March 2009 (discussing pharmaceutical technology).

334 From a survey response by one MNPC, Dhaka, Bangladesh, 22 January 2009.

335 See Steven C. Carlson, ‘Note, Patent Pools and the Antitrust Dilemma’, Yale Journal on Regulation 16 (1999): 352–9.

336 See Robert P. Merges, ‘Institutions for Intellectual Property Exchange: The Case of Patent Pools’, in Intellectual Products: Novel Claims to Protection and their Boundaries, ed. by Rochelle Dreyfuss (2001).

337 Manisha Singh Nair, Rationality of a Patent Pool (12 December 2009), http://ipfrontline.com/2009/04/rationality-of-a-patent-pool

338 Ibid.

339 Ibid.

340 WHO, KEI, Intergovernmental Working Group Submission on Collective Management of Intellectual Property—‘The Use of Patent Pools to Expand Access to Needed Medical Technologies’ (30 September 2007), p. 3, http://www.who.int/phi/public_hearings/second/contributions_section2/Section2_ManonRess-PatentPool.pdf

341 Ibid.

342 Ibid.

343 David de Ferranti, ‘Can Patent Pools Get More AIDS Drugs to Patients?’, Huffington Post (9 April 2012), http://www.huffingtonpost.com/david-de-ferranti/aids-drugs_b_1404218.html

344 Ibid.

345 For details about the working procedure of the Medicines Patent Pool (MPP), see About the MPP, Medicines Patent Pool, http://www.medicinespatentpool.org/about/

346 Ibid.

347 Ibid.

348 How it Works, Medicines Patent Pool, http://www.medicinespatentpool.org/wp-content/uploads/how-it-works-diagram.png

349 ‘Can Patent Pools Get More AIDS Drugs to Patients?’.

350 Article 66.2 of the TRIPS Agreement provides that “Developed country Members shall provide incentives to enterprises and institutions in their territories for the purpose of promoting and encouraging technology transfer to least-developed country Members in order to enable them to create a sound and viable technological base”. As Carlos Correa states, “This article puts an obligation on developed Member countries to provide incentives to enterprises and institutions. However, the precise nature of the incentives is not established; only their end is spelled out: to enable LDC members ‘to create a sound and viable technological base’”. Carlos Correa, ‘Intellectual Property in LDCs: Strategies for Enhancing Technology Transfer and Dissemination’ (UNCTAD The Least Developed Countries Report 2007, Background Paper No. 4, 2007), pp. 3, 18, http://unctad.org/Sections/ldc_dir/docs/ldcr2007_Correa_en.pdf

351 “Article 67 of the TRIPS Agreement sets out developed countries’ commitments on technical cooperation. This Article provides that developed country members must provide, on request and on mutually agreed terms and conditions, technical and financial cooperation in favour of developing and least-developed country members to facilitate TRIPs implementation. Such assistance can include assistance in drafting laws and regulations to protect IPRs as well as the establishment or reinforcement of domestic enforcement agencies”. Farhana Yamin, ‘Globalisation and the International Governance of Modern Biotechnology: IPRs, Biotechnology and Food Security’, Foundation for International Environmental Law and Development, p. 25, http://www.sristi.org/mdpipr2004/other_readings/OR%2042.pdf

352 During interviews, this was supported by IP academics, pharmaceutical researchers and public health activists working with national and international NGOs that were involved in the public health sector in Bangladesh.

353 ‘Good Practice Guide’, p. 49, http://content.undp.org/go/cms-service/stream/asset/?asset_id=3259443

354 Peter Drahos, ‘BITS and BIPS: Bilateralism in Intellectual Property’, Journal of World Intellectual Property 4 (2001): 791, 800–01, https://www.anu.edu.au/fellows/pdrahos/articles/pdfs/2001bitsandbips.pdf

355 ‘Good Practice Guide’, p. 49; Drahos, p. 802.

356 ‘Global Communication on HIV and the Law’, p. 25; see also ‘Good Practice Guide’ and ‘TRIPS-plus Free Trade Agreements and Access to Medicines’, p. 41.

357 The Trans-Pacific Partnership Agreement (TPP) was based on an agreement originally concluded in 2005 between Brunei, Chile, New Zealand and Singapore, and now also negotiated between Australia, Malaysia, Peru, the US and Vietnam. See ‘TRIPS Was Never Enough’, p. 447.

358 The Anti-Counterfeiting Trade Agreement (ACTA) is a multinational treaty that aims to establish an international intellectual property framework targeting primarily counterfeit goods, generic medicines and copyright infringement on the Internet. It would create a new governing body outside existing forums such as the WTO, the WIPO and the UN. It has yet to come into effect. ACTA has been criticised by MSF for endangering access to medicines in developing countries. See ‘A Blank Cheque For Abuse: ACTA and Its Impact on Access to Medicines’, Médecins Sans Frontières Access Campaign (17 February 2012), https://www.msfaccess.org/sites/default/files/MSF_assets/Access/Docs/Access_Briefing_ACTABlankCheque_ENG_2012.pdf

359 LDCs may need to adopt TRIPS-compliant national law, including pharmaceutical patents, despite the fact that they are entitled to a transition period until 1 January 2016 to fully implement patent protection for pharmaceuticals—and as per the decision of June 2013, have a further exemption until 1 July 2021 for general TRIPS obligations and possibly a separate extension for pharmaceutical patents beyond 2021.

360 See Gaelle P. Krikorian and Dorota M. Szymkowiak, ‘Intellectual Property Rights in the Making: The Evolution of Intellectual Property Provisions in US Free Trade Agreements and Access to Medicine’, Journal of Intellectual Property Law 10 (2007): 388; see also ‘Good Practice Guide’.

361 ‘Trading Away Health: How the US’s Intellectual Property Demands for the Trans-Pacific Partnership Agreement Threaten Access to Medicines’, Médecins Sans Frontières Access Campaign, 12 (August 2012), http://aids2012.msf.org/wp-content/uploads/2012/07/TPP-Issue-Brief-IAC-July2012.pdf

362 See Annette Kur and Henning Grosse Ruse-Khan, ‘Enough is Enough: The Notion of Binding Ceilings in International Intellectual Property Protection’ (Max Planck Institute for Intellectual Property, Competition and Tax Law, Research Paper Series No. 09-01, 8 December 2008), p. 44, http://ssrn.com/abstract=1326429

363 Ibid., p. 1.

364 Ibid.

365 See generally ‘Universal Minimum Standards’, p. 345.

366 Ibid., p. 351.

367 See Global Intellectual Property Center, ‘TRIPS: Floor Versus Ceiling?’ (26 January 2010), p. 4, http://www.theglobalipcenter.com/sites/default/files/reports/documents/TRIPS_FloorVsCeiling_WP_1_10_2.pdf

368 Since 2003, Bangladesh has been negotiating a Trade and Investment Framework Agreement (TIFA) with the US to include provisions on IP. It was finalised for ratification in 2009 and then revised further in 2012, but ratification was postponed by the Government of Bangladesh with an eye to the upcoming election. There is an assumption that the proposed TIFA text could impose TRIPS-plus obligations on Bangladesh. When requested to disclose the draft TIFA text for the sake of avoiding controversies, an official of the US mission in Dhaka said that Washington was not in a position to make the draft public before signing the agreement, and that “There are other drafts of TIFA and this one is similar to that”. See Khawaza Main Uddin, ‘Govt Inching Closer Towards Signing TIFA with US’, Business Info Bangladesh (7 November 2009), https://web.archive.org/web/20101120054050/http://bizbangladesh.com/business-news-2758.php (accessed by searching the Internet Archive index).

369 Sheikh Hasina, Prime Ministerof Bangladesh, Speech to the 64th WHA (17 May 2011), http://www.who.int/mediacentre/events/2011/wha64/sheikh_hasina_speech_20110517/en/

370 Ibid.

371 “Special and Differential Treatment” (S&D) may be sought to extend the transition period until graduation to a higher level of social and economic development and, hence, an ideal situation for the introduction of pharmaceutical patents case by case or under a country-driven approach with recourse to the WTO. See Thomas Cottier, ‘From Progressive Liberalization to Progressive Regulation in WTO Law’, Journal of International Economic Law 9.4 (2006): 414–19.

372 S&D is a set of GATT provisions (GATT 1947, Article XVIII) that exempts developing countries from the same strict trade rules and disciplines of more industrialised countries. For example, in the Uruguay Round Agreement on Agriculture, LDCs are exempt from any reduction commitments and developing countries are given longer to phase in export subsidy and tariff reductions than the more industrialised countries. Using this principle, exemption from introducing pharmaceutical patents may also be extended as long as problems of access to pharmaceuticals and a low level of social and economic development persists in the particular country. See, for example, Javier Lopez Gonzalez, Maximillano Mendez Parra and Anirudh Shingal, ‘TRIPS and Special and Differential Treatment—Revisiting the Case for Derogations in Applying Patent Protection for Pharmaceuticals in Developing Countries’ (Draft Working Paper No. 2011–37, NCCR Trade Regulation, 2011), https://www.sussex.ac.uk/webteam/gateway/file.php?name=wp-2011-37.pdf&site=261

373 WTO Council for TRIPS, ‘Elements Paper on the Extension of the Transition Period under Article 66.1 of the TRIPS Agreement’, IP/C/W/566 (11 November 2011), https://docs.wto.org/dol2fe/Pages/FE_Search/DDFDocuments/41380/Q/IP/C/W566.pdf&usg=AFQjCNHwAYKL_So9eXKC_QSxp9a-k5O5-w&cad=rja

374 This position was supported by all the large, medium and small local pharmaceutical companies in Bangladesh that participated in the survey.

375 During the surveys, this position was supported by all the MNPCs operating in Bangladesh.

376 Interview with an expert at the DDA in Bangladesh, in Dhaka, Bangladesh, 12 January 2012.

377 Interview with a deputy registrar from the DPDT, in Dhaka, Bangladesh, 22 January 2012.

378 See WHO (19 WHO Drug Info), p. 238.

379 See Sudip Chaudhuri, ‘The WTO and India’s Pharmaceutical Industry’ (2005); ‘TRIPS and Changes in Pharmaceutical Patent Regime’.

380 Based on the survey data from local large, medium and small pharmaceutical companies in Bangladesh. However, MNPCs made no comments on this.

381 See Uma Suthersanen, ‘Utility Models and Innovation in Developing Countries’ (February 2006), pp. 5–7, http://unctad.org/en/Docs/iteipc20066_en.pdf

382 Suerie Moon J. Bermudez, E. ‘t Hoen, ‘Innovation and Access to Medicines for Neglected Populations: Could a Treaty Address a Broken Pharmaceutical R&D System?’, PLoS Med 9.5 (2012), e1001218, http://dx.doi.org/10.1371/journal.pmed.1001218

383 See Shamnad Basheer, ‘The Invention of an Investment Incentive for Pharmaceutical Innovation’, Journal of World Intellectual Property 15 (2012): 305, http://ssrn.com/abstract=2203440

384 Ibid., pp. 46–48.

385 Ibid.

386 Ibid., p. 309.

387 Carlos Correa, ‘TRIPS and R&D Incentives in the Pharmaceutical Sector’ (Communication on Macroeconomics and Health, Working Paper No.WG2:11, November2011),p.19,http://library.cphs.chula.ac.th/Ebooks/HealthCareFinancing/WorkingPaper_WG2/WG2_11.pdf

388 See generally Globalization and Access to Drugs.

389 Open source is “a way of sharing data, expertise, and resources to increase collaboration, transparency, and cumulative public knowledge. It has been used in the software field since its infancy half a century ago, and tried in the bio-pharma field over the last decade”. Hassan Masum and Rachelle Harris, Open Source for Neglected Diseases: Magic Bullet or Mirage? (Washington, DC: Results for Development Institute, 2011), http://healthresearchpolicy.org/sites/healthresearchpolicy.org/files/assessments/files/OS_for_NTDs_Consultation Draft.pdf. In addition, a number of open source initiatives have been launched in the medical field, such as India’s Council of Scientific and Industrial Research, which is working on open source drug discovery to develop drugs for the treatment of drug-resistant tuberculosis (TB). See Council of Scientific and Industrial Research, ‘NMITLI Achievements’, http://www.csir.res.in/External/Heads/collaborations/sa%20old%20new.pdf. “In the long run, it may help minimize duplication of effort, and create a ‘commons’ of knowledge and data from which future innovation can grow”. Open Source for Neglected Diseases, p. 3.

390 See Stephen M. Maurer A. Rai, and A. Sali, ‘Finding Cures for Tropical Diseases: Is Open Source an Answer?’, PLoS Med 1.3 (2004), e56, http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0010056

391 “The Tropical Diseases Initiative (TDI) modelled itself explicitly on open source approaches as early as 2004 and produced a set of potential drug targets from pathogen genomes that have been released under a Creative Commons license for further work”. Open Source for Neglected Diseases, p. 7.

392 “TDR Targets is a WHO/TDR database that facilitates prioritization of potential drug targets across tropical disease areas”. It “brings together information on genomics, structural data, inhibitors and targets, and drug ability”. Ibid.

393 Collaborative Drug Discovery is a California-based company that has “created a platform for selective sharing of collaborative drug discovery data … It allows preclinical biological and chemical drug discovery data to be securely stored, shared, analysed, and collaborated upon through a web interface”. Ibid., p. 6.

394 The Lilly TB Drug Discovery Initiative is a not-for-profit public-private partnership headquartered in Seattle, Washington, with a mission to accelerate early-stage drug discovery and help identify the TB drugs of the future. It has opened access to its drug discovery expertise and scientific resources—such as its proprietary library of 500,000 compounds and innovative chemistry research tools—to be applied to the search for new drugs to fight TB. See About the Initiative, Lilly TB Drug Discovery Initiative, https://www.lilly.com/About/default.aspx

395 A social business is a non-loss, non-dividend company designed to address a social objective. Muhammad Yunus, Building Social Business: The New Kind of Capitalism That Serves Humanity’s Most Pressing Needs (Public Affairs, 2010). In this type of business organisation, profits are used to expand the company’s reach and improve the product or service to a greater extent than in a traditional for- profit corporation. Thus, investors receive no dividends or extra payments apart from their initial investment. See Muhammad Yunus, Creating a World without Poverty: Social Business and the Future of Capitalism (Public Affairs, 2008). The main organisations promoting and incubating social businesses are the Yunus Centre in Bangladesh and the Grameen Creative Lab in Germany.

396 See Bryan Mercurio, ‘Resolving the Public Health Crisis in the Developing World: Problems and Barriers of Access to Essential Medicines’, Northwestern University Journal of International Human Rights 5 (2006): 1, 40.

397 Ibid.

398 WHO, ‘Promoting Access to Medical Technologies and Innovation: Intersections between Public Health, Intellectual Property and Trade’ (2012), p. 53, https://www.wto.org/english/res_e/booksp_e/pamtiwhowipowtoweb13_e.pdf

399 Ibid., p. 14.

Table des illustrations

Titre Figure 4.1: Working procedure of the Medicines Patent Pool348
URL http://books.openedition.org/obp/docannexe/image/3139/img-1.jpg
Fichier image/jpeg, 80k